Cleared Traditional

K210736 - doctorgram Stethoscope DES-I

K210736 is an FDA 510(k) clearance for doctorgram Stethoscope DES-I, manufactured by Gv Concepts. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K210736 · Gv Concepts · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
138d
Days
Class 2
Risk

K210736 is an FDA 510(k) clearance for the doctorgram Stethoscope DES-I. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Gv Concepts (San Jose, US). The FDA issued a Cleared decision on July 27, 2021 after a review of 138 days - within the typical 510(k) review window.

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: 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 Gv Concepts devices

FDA 510(k) Submission Details - K210736

510(k) Number K210736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2021
Decision Date July 27, 2021
Days to Decision 138 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
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

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 Peers - DQD Stethoscope, Electronic

All 58
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K210736.
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K203007 · Chip Ideas Electronics S.L. · Oct 2020