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FDA 510(k)

AViTA Arm Type Blood Pressure Monitor Cuff

K-Number: K250765 · 2025-09-03

ApplicantAvita Corporation
Decision Date2025-09-03
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AViTA Arm Type Blood Pressure Monitor Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2025-09-03 under 510(k) number K250765. The device is classified under product code DXQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AViTA Arm Type Blood Pressure Monitor Cuff?

AViTA Arm Type Blood Pressure Monitor Cuff is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Avita Corporation. The 510(k) number is K250765.

When did AViTA Arm Type Blood Pressure Monitor Cuff receive FDA 510(k) clearance?

AViTA Arm Type Blood Pressure Monitor Cuff received FDA 510(k) clearance on 2025-09-03, under 510(k) number K250765.

Who is the listed applicant for AViTA Arm Type Blood Pressure Monitor Cuff?

The FDA 510(k) record lists Avita Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AViTA Arm Type Blood Pressure Monitor Cuff?

The FDA product code for AViTA Arm Type Blood Pressure Monitor Cuff is DXQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07240831Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)RECRUITINGNCT07523269WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure ControlRECRUITINGNCT05673408NIBP Validation StudyRECRUITINGNCT06508619Blood Pressure Treatment by the Corsano CardioWatch 287-2 Evaluation StudyCOMPLETEDNCT06973590Blood Flow Restriction and Transcutaneous Electrical Nerve Stimulation on Motor Function in StrokeRECRUITINGNCT07633886Multi-Centre Based Evaluation of the Performance and Safety of the Corsano CardioWatch 287-2 Blood Pressure Monitoring Device at Wrist Against BP-Cuff Measurements (COR-BP)NOT_YET_RECRUITING

Other records listing Avita Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250129AViTA Breast PumpK252448AViTA Pulse Oximeter (SP61)K242455AViTA Pulse Oximeter (SP62B)K241852Nasal Aspirator (NS 13)K242193Arm Type Blood Pressure Monitor (BPM82)K223399AViTA Pulse Oximeter

View all 10 devices →

Related Devices (Code: DXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254287Medline Reusable Blood Pressure CuffMedline Industries, LPK260747YP-710T Series NIBP Cuff;YP-840T Series Disposable CuffNihon Kohden CorporationK253089NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)Shenzhen Best Electronics Co., Ltd.K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)Unimed Medical Supplies, Inc.K251745Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)Baxter Healthcare CorporationK251045Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)Unimed Medical Supplies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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