Cleared Traditional

K082542 - ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A

K082542 is an FDA 510(k) clearance for ANEROID SPHYGMOMANOMETER WITH STETHOSCO..., manufactured by Cardicare Company, Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K082542 · Cardicare Company, Ltd. · Cardiovascular device
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Sep 2008
Decision
14d
Days
Class 2
Risk

K082542 is an FDA 510(k) clearance for the ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Cardicare Company, Ltd. (Hangzhou, Zhejiang, CN). The FDA issued a Cleared decision on September 17, 2008 after a review of 14 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

FDA 510(k) Submission Details - K082542

510(k) Number K082542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2008
Decision Date September 17, 2008
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 158
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K082542.
DEVON ACCUBP CUFF
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K080189 · Trimline Medical Products Corp. · Aug 2008
ANEROID SPHYGMOMANOMETER, MODEL KT-A01
K081951 · Wenzhou Kindcare Import & Export Co., Ltd. · Aug 2008
DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
K080366 · Zefon Intl. · Jun 2008