Cleared Traditional

K191209 - Aneroid Type Blood Pressure Kit

K191209 is the FDA 510(k) clearance for Aneroid Type Blood Pressure Kit by Dongguan Mars Medical Products Co., Ltd.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K191209 · Dongguan Mars Medical Products Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2019
Decision
43d
Days
Class 2
Risk

K191209 is an FDA 510(k) clearance for the Aneroid Type Blood Pressure Kit. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Dongguan Mars Medical Products Co., Ltd. (Dani Village, Shatian Town, Dongguan Cit, CN). The FDA issued a Cleared decision on June 18, 2019 after a review of 43 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 Dongguan Mars Medical Products Co., Ltd. devices

Submission Details

510(k) Number K191209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2019
Decision Date June 18, 2019
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
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 Consultant

Guangzhou Junyi Information Technology Co., Ltd.
Jinghua Zhou

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 73
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K191209.
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K192500 · Honsun (Nantong) Co., Ltd. · Apr 2020
Disposable NIBP Cuff
K193629 · Shenzhen Changke Connect Electronics Co., Ltd. · Mar 2020
Reusable NIBP Cuff
K191253 · Shenzhen Changke Connect Electronics Co., Ltd. · Sep 2019
RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope
K190902 · Wenzhou Renhua Instruments Co., Ltd. · May 2019
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K182433 · Shenzhen Caremed Medical Technology Co., Ltd. · Dec 2018
Reusable NIBP Cuff
K173197 · Orantech, Inc. · Aug 2018