Cleared Traditional

K161035 - Medline Singe Patient Use Blood Pressure Cuff

K161035 is an FDA 510(k) clearance for Medline Singe Patient Use Blood Pressur..., manufactured by Medline Industries, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K161035 · Medline Industries, Inc. · Cardiovascular device
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Jun 2016
Decision
61d
Days
Class 2
Risk

K161035 is an FDA 510(k) clearance for the Medline Singe Patient Use Blood Pressure Cuff. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on June 13, 2016 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K161035

510(k) Number K161035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2016
Decision Date June 13, 2016
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXQ Blood Pressure Cuff

All 166
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K161035.
Reusable Blood Pressure Cuff
K171889 · Suzhou Minhua Medical Apparatus Supplies Co., Ltd. · Dec 2017
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K173044 · Ningbo Albert Novosino Co., Ltd. · Nov 2017
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
K160530 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Nov 2016
Cogent Hemodynamic Monitoring System
K152006 · Icu Medical, Inc. · May 2016
Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
K153251 · Ningbo Free Trade Zone Tenso Medical Instruments Co., Ltd. · Apr 2016
Bpump Blood Pressure Cuff
K151810 · Shenzhen Pump Medical System Co., Ltd. · Dec 2015