Cleared Traditional

Reusable NIBP Cuff (K191253) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191253 · Shenzhen Changke Connect Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
131d
Days
Class 2
Risk

K191253 is an FDA 510(k) clearance for the Reusable NIBP Cuff. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Shenzhen Changke Connect Electronics Co., Ltd. (Longgang District, Shenzhen, CN). The FDA issued a Cleared decision on September 17, 2019 after a review of 131 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Changke Connect Electronics Co., Ltd. devices

Submission Details

510(k) Number K191253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2019
Decision Date September 17, 2019
Days to Decision 131 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
6d slower than avg
Panel avg: 125d · This submission: 131d
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

Chonconn Medical Device Consulting Co., Ltd.
Kevin 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 59
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K191253.
Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
K193259 · Little Doctor Electronic (Nantong)Co.,Ltd · Jul 2020
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
Aneroid Type Blood Pressure Kit
K191209 · Dongguan Mars Medical Products Co., Ltd. · Jun 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