Cleared Traditional

Aneroid Sphygmomanometer (K222652) - FDA 510(k) Clearance

Also marketed or referenced as:
Single Patient Use Aneroid Sphygmomanometer

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

K222652 · Cardicare Company, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2022
Decision
88d
Days
Class 2
Risk

K222652 is an FDA 510(k) clearance for the Aneroid Sphygmomanometer. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Cardicare Company, Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on November 28, 2022 after a review of 88 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 Cardicare Company, Ltd. devices

Submission Details

510(k) Number K222652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2022
Decision Date November 28, 2022
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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

Irc
Charles Mack

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 K222652.
NIBPCuff
K231961 · Shenzhen Sino-K Medical Technology Co.,Ltd · Aug 2023
Aneroid Sphygmomanometer
K230859 · Wenzhou Kangshun Medical Devices Co.,Ltd · Jun 2023
ONE-CUF
K230145 · Ge Medical Systems Information Technologies, Inc. · Mar 2023
Disposable Blood Pressure Cuff
K222420 · Wenzhou Xikang Medical Instruments Co., Ltd. · Nov 2022
Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201
K221857 · Zhejiang Lude Technology Development Co., Ltd. · Oct 2022
WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203
K212416 · Wenzhou Xikang Medical Instruments Co., Ltd. · May 2022