Cleared Traditional

K152465 - Disposable Blood Pressure Cuff

K152465 is an FDA 510(k) clearance for Disposable Blood Pressure Cuff, manufactured by Shenzhen Vistar Medical Supplies Co., Ltd.. The device is a Class 2 Cardiovascular device with 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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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

FDA 510(k) Submission Details - K152465

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Beijing Believe Tech.Service Co., Ltd.
Ray Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXQ Blood Pressure Cuff

All 132
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K152465.
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
Reusable Blood Pressure Cuff
K152468 · Shenzhen Vistar Medical Supplies Co., Ltd. · Oct 2015
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M
K152363 · Philips Medical Systems · Oct 2015
ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT
K152801 · Statcorp Medical · Oct 2015