Cleared Traditional

K152465 - Disposable Blood Pressure Cuff

K152465 is the FDA 510(k) clearance for Disposable Blood Pressure Cuff by Shenzhen Vistar Medical Supplies Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K152465 · Shenzhen Vistar Medical Supplies Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 2015
Decision
59d
Days
Class 2
Risk

K152465 is an FDA 510(k) clearance for the Disposable Blood Pressure Cuff. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Shenzhen Vistar Medical Supplies Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 29, 2015 after a review of 59 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.

View all Shenzhen Vistar Medical Supplies Co., Ltd. devices

Submission Details

510(k) Number K152465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2015
Decision Date October 29, 2015
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K152465.
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K152363 · Philips Medical Systems · Oct 2015
ANDON BLOOD PRESSURE CUFF
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