Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Medline Singe Patient Use Blood Pressure Cuff

K-Number: K161035 · 2016-06-13

ApplicantMedline Industries, Inc.
Decision Date2016-06-13
Product CodeDXQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Medline Singe Patient Use Blood Pressure Cuff is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-06-13 under 510(k) number K161035. 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 Medline Singe Patient Use Blood Pressure Cuff?

Medline Singe Patient Use Blood Pressure Cuff is a medical device that received FDA 510(k) clearance on 2016-06-13. The listed applicant is Medline Industries, Inc.. The 510(k) number is K161035.

When did Medline Singe Patient Use Blood Pressure Cuff receive FDA 510(k) clearance?

Medline Singe Patient Use Blood Pressure Cuff received FDA 510(k) clearance on 2016-06-13, under 510(k) number K161035.

Who is the listed applicant for Medline Singe Patient Use Blood Pressure Cuff?

The FDA 510(k) record lists Medline Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline Singe Patient Use Blood Pressure Cuff?

The FDA product code for Medline Singe Patient Use Blood Pressure 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.

NCT07613892Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure AdhesivesCOMPLETEDNCT07734220Evaluation of Two Heel Protection Devices to Assess Off-loading Via Pressure Mapping.COMPLETED

Other records listing Medline Industries, Inc. 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.

K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)K222665Medline UNITE® Ankle Fusion Plating SystemK213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeK212911Konig Mogen ClampK220565Hudson RCI Triflo II Incentive Deep Breathing Exerciser

View all 74 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 CorporationK250765AViTA Arm Type Blood Pressure Monitor CuffAvita Corporation

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.

↑