Cleared Traditional

K141998 - SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS

K141998 is an FDA 510(k) clearance for SAMA DISPOSABLE BLOOD PRESSURE CUFF BAR..., manufactured by Pinghu Sama Medical Packing Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K141998 · Pinghu Sama Medical Packing Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2014
Decision
58d
Days
Class 2
Risk

K141998 is an FDA 510(k) clearance for the SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Pinghu Sama Medical Packing Co., Ltd. (New Milford, US). The FDA issued a Cleared decision on September 19, 2014 after a review of 58 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 Pinghu Sama Medical Packing Co., Ltd. devices

FDA 510(k) Submission Details - K141998

510(k) Number K141998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2014
Decision Date September 19, 2014
Days to Decision 58 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
67d faster than avg
Panel avg: 125d · This submission: 58d
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 132
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K141998.
Minhua Disposable Blood Pressure Cuff
K143728 · Suzhou Minhua Medical Apparatus · May 2015
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K143332 · Koven Technology, Inc. · Apr 2015
Disposable Blood Pressure Cuff Guard
K150227 · Pinhu Sama Medical Packing Co., Ltd. · Apr 2015
GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF
K140874 · Shanghai Goahui Rubber and Plastic Company · Sep 2014
SPHYGMOMANOMETER
K141392 · Suzhou JJ Meter Co., Ltd. · Jul 2014
ANDON BLOOD PRESSURE CUFF
K133117 · Andon Health Co, Ltd. · Mar 2014