Cleared Traditional

K141392 - SPHYGMOMANOMETER

K141392 is an FDA 510(k) clearance for SPHYGMOMANOMETER, manufactured by Suzhou JJ Meter Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K141392 · Suzhou JJ Meter Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
36d
Days
Class 2
Risk

K141392 is an FDA 510(k) clearance for the SPHYGMOMANOMETER. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Suzhou JJ Meter Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on July 2, 2014 after a review of 36 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 Suzhou JJ Meter Co., Ltd. devices

FDA 510(k) Submission Details - K141392

510(k) Number K141392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2014
Decision Date July 02, 2014
Days to Decision 36 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
89d faster than avg
Panel avg: 125d · This submission: 36d
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 K141392.
Disposable Blood Pressure Cuff Guard
K150227 · Pinhu Sama Medical Packing Co., Ltd. · Apr 2015
SAMA DISPOSABLE BLOOD PRESSURE CUFF BARRIERS
K141998 · Pinghu Sama Medical Packing Co., Ltd. · Sep 2014
GH DISPOSABLE AND GH REUSABLE BLOOD PRESSURE CUFF
K140874 · Shanghai Goahui Rubber and Plastic Company · Sep 2014
ANDON BLOOD PRESSURE CUFF
K133117 · Andon Health Co, Ltd. · Mar 2014
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF
K130942 · Legacy Medical, Inc. · Oct 2013
RADIAL-CUF NON-INVASIVE BLOOD PRESSURE CUFF
K123996 · Ge Medical Systems Information Technologies, Inc. · Apr 2013