Cleared Traditional

K201299 - HD Steth

K201299 is the FDA 510(k) clearance for HD Steth by Hd Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQD) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K201299 · Hd Medical, Inc. · Cardiovascular device
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Jul 2020
Decision
56d
Days
Class 2
Risk

K201299 is an FDA 510(k) clearance for the HD Steth. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Hd Medical, Inc. (Santa Clara, US). The FDA issued a Cleared decision on July 10, 2020 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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 Hd Medical, Inc. devices

Submission Details

510(k) Number K201299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2020
Decision Date July 10, 2020
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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
Prithul Bom

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 - DQD Stethoscope, Electronic

All 58
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K201299.
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Eko CORE
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Electronic Stethoscope
K191667 · Hefei Mintti Medical Technology Co., Ltd. China · Dec 2019
Vivio System
K183710 · Avicena, LLC · Oct 2019