System, Measurement, Blood-Pressure, Non-Invasive
FDA product code DXN · 1166 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.1130
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-11-09 – 2026-09-10
DXN
2026-09-10
DXN
2026-09-03
Happy Health Blood Pressure Monitor
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DXN
2026-08-31
Automatic Digital Blood Pressure monitor (LD-526)
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DXN
2026-08-26
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)
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DXN
2026-08-13
BP Go (BPP-855)
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DXN
2026-08-13
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)
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DXN
2026-07-23
Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)
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DXN
2026-07-23
Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G)
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DXN
2026-06-18
Wrist Blood Pressure Monitor (XW-05)
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DXN
2026-06-16
VicorderCS (VCS-SYS-1100)
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DXN
2026-06-15
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
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DXN
2026-06-03
Upper arm electronic blood pressure monitor (XB-01)
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DXN
2026-05-20
Blood Pressure Monitor (W06LT)
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DXN
2026-05-14
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
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DXN
2026-05-06
BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000)
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DXN
2026-04-28
Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
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DXN
2026-04-28
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L)
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DXN
2026-04-21
Korotkoff sound blood pressure monitor
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DXN
2026-04-01
Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro
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DXN
2026-04-01
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
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DXN
2026-03-26
Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).)
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DXN
2026-03-05
YUWELL® Electronic Blood Pressure Monitor (YE630CR)
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DXN
2026-02-23
YUWELL® Electronic Blood Pressure Monitor (YE650AR)
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DXN
2026-02-13
Wrist Blood Pressure Monitor (BPM-W1VL)
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DXN
2026-02-13
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)
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DXN
2026-02-13
Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
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DXN
2026-01-12
Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i)
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DXN
2026-01-09
Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D)
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DXN
2025-12-19
Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L)
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DXN
2025-10-27
Blood Pressure Monitor (B73, BE23T)
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DXN
2025-10-09
Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
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DXN
2025-10-02
Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116)
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DXN
2025-09-03
Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856)
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DXN
2025-08-06
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B)
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DXN
2025-08-04
iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wireless Blood Pressure Monitor(BP-300CV);iHealth Compare S Wireless Blood Pressure Monitor(BP-300V);iHealth Wireless Blood Pressure Monitor(BPX1);iHealth Blood Pressure Monitor(KD-595);iHealth Track Pro Connected Blood Pressure Monitor(KN-550LT);Semi Automatic Blood Pressure Monitor(KD-388N);Arm Blood Pressure Monitor(KD-553);Arm Blood Pressure Monitor(KD-557BR);Arm Blood Pressure Monitor(KD-558);Arm Blood Pr
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DXN
2025-07-30
ArteVu
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DXN
2025-07-16
Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603)
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DXN
2025-07-14
Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24)
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DXN
2025-07-02
G0 Blood Pressure Monitoring System (G0)
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DXN
2025-06-26
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
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DXN
2025-05-02
Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); Wrist Blood Pressure Monitor (WRS-35B); Wrist Blood Pressure Monitor (AOJ-35D); Wrist Blood Pressure Monitor (AOJ-35E); Wrist Blood Pressure Monitor (AOJ-35F); Wrist Blood Pressure Monitor (AOJ-35G); Wrist Blood Pressure Monitor (WRS-35G); Wrist Blood Pressure Monitor (WRS-35H); Wrist Blood Pressure Monitor (WRS-35K); Wrist Blood Pressure Monitor (WRS-35N); Wrist Blood Pressure Monitor (WRS-35P); Wrist Bloo
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DXN
2025-04-30
Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+);
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DXN
2025-04-24
Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm Blood Pressure Monitor (ARM-30K); Arm Blood Pressure Monitor (ARM-90B)
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DXN
2025-04-08
Globalcare Blood Pressure Monitor (GUS610)
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DXN
2025-03-14
KOROT Blood Pressure Monitor (KOROT P3 Accurate)
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DXN
2025-02-21
Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z))
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DXN
2025-02-19
Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355)
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DXN
2025-02-11
Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
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DXN
2025-02-07
Electronic Blood Pressure Monitor
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DXN
2025-02-05
Accurate Mini Non-invasive blood pressure monitor (AMB-001)
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DXN
2025-02-03
Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09)
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DXN
2025-01-30
Wrist Blood Pressure Monitor (OHMS11, OHMS12)
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DXN
2025-01-23
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
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DXN
2025-01-14
BB-613-BPM
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DXN
2025-01-13
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193)
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DXN
2025-01-10
Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298)
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DXN
2024-11-26
Arm Blood Pressure Monitor (model: BPM-A7VL)
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DXN
2024-10-24
Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01)
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DXN
2024-10-22
Arm Type Blood Pressure Monitor (BPM82)
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DXN
2024-10-16
Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206)
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DXN
2024-10-04
Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)
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DXN
2024-08-21
Blood Pressure Monitor (TMB-2092-G)
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DXN
2024-07-03
Upper Arm Electronic Blood Pressure Monitor
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DXN
2024-06-14
Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61)
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DXN
2024-06-07
Blood Pressure Monitor (BBZ32-AA01)
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DXN
2024-05-31
Blood Pressure Monitor (TMB-2296-BT)
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DXN
2024-04-29
Blood Pressure Monitor (TMB-2287-B)
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DXN
2024-04-22
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5811BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5810VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5810BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5920VA); Fully Automatic Electronic Blood Pressure Monitor (KD-5920BT); Fully Automatic Electronic Blood Pressure Monitor (KD-5923TS)
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DXN
2024-03-26
Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
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DXN
2024-03-19
Blood Pressure Monitor
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DXN
2024-03-15
Wrist Blood Pressure Monitor (222); Wrist Blood Pressure Monitor (222BT); Wrist Blood Pressure Monitor (W1681BL); Wrist Blood Pressure Monitor (W1681BT); Wrist Blood Pressure Monitor (W1681R)
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DXN
2024-01-26
Arm-type Fully Automatic Digital Blood Pressure Monitor
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DXN
2024-01-04
Pursuant Health Kiosk (G1.D5)
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DXN
2023-12-20
Blood Pressure Monitor
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DXN
2023-12-15
Digital Blood Pressure Monitor (Model: YB-800)
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DXN
2023-12-11
Wrist Blood Pressure Monitor
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DXN
2023-12-08
SimpleSense-BP, SimpleSense-BP Software Application
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DXN
2023-12-05
Electronic Blood Pressure Monitor
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DXN
2023-12-05
Electronic Blood Pressure Monitor, model: HTD6602US
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DXN
2023-11-28
Blood Pressure Monitor
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DXN
2023-11-28
Digital Blood Pressure Monitor
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DXN
2023-11-22
Blood pressure monitor
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DXN
2023-11-22
Digital Blood Pressure Monitor (Arm Type)
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DXN
2023-10-27
Electronic Blood Pressure Monitor
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DXN
2023-10-24
Acumen IQ finger cuff
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DXN
2023-10-11
Arm Blood Pressure Monitor
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DXN
2023-09-29
Boppli Infant Blood Pressure Monitor
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DXN
2023-09-18
Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221)
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DXN
2023-09-07
Digital Blood Pressure Monitor WBP Series
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DXN
2023-09-07
Arm Blood Pressure Monitor
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DXN
2023-08-25
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor
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DXN
2023-08-25
Wrist Type Blood Pressure Monitor (W05,W1101L)
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DXN
2023-08-11
Electronic Blood Pressure Monitor
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DXN
2023-08-02
BPBIO750
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DXN
2023-07-26
Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B
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DXN
2023-06-30
Blood Pressure Monitor
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DXN
2023-06-29
Upper Arm Blood Pressure Monitor
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DXN
2023-06-28
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K
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DXN
2023-06-21
Accurate 24 Non-invasive blood pressure monitor
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DXN
2023-06-14
Electronic Blood Pressure Monitor
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