Cleared Traditional

Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope (K211084) - FDA 510(k) Clearance

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

K211084 · Shanghai Caremate Medical Device Co., Ltd. · Cardiovascular device
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Oct 2021
Decision
190d
Days
Class 2
Risk

K211084 is an FDA 510(k) clearance for the Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Shanghai Caremate Medical Device Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on October 19, 2021 after a review of 190 days - an extended review 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: 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 Shanghai Caremate Medical Device Co., Ltd. devices

Submission Details

510(k) Number K211084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2021
Decision Date October 19, 2021
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
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 Peers - DXQ Blood Pressure Cuff

All 59
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K211084.
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
Reusable NIBP Cuff
K211747 · Shenzhen Coreray Technology Co., Ltd. · Sep 2021
Aneroid Sphygmomanometer
K203620 · Wuxi Exanovo Medical Instrument Co., Ltd. · Mar 2021
Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
K203652 · Jkh USA, LLC · Jan 2021