Skip to content

Doctorgram Stethoscope DES-I

by Gv Concepts

510(k) K210736

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210736 Date27 Jul 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQD
Device Class
Class II
Regulation
21 CFR Part 870.1875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Doctorgram Stethoscope DES-I is an electronic stethoscope designed for auscultation of cardiac and other internal organ sounds. It combines traditional stethoscope functionality with digital amplification and recording capabilities to enhance diagnostic accuracy for healthcare professionals.

This device is supplied as a reusable stethoscope paired with a smartphone application for data processing and storage. It is classified as Class II under FDA regulations (product code DQD) and received FDA 510(k) clearance in July 2021. The device is intended for use in clinical settings and does not require MRI safety considerations. Multiple registration numbers (e.g., 3013557562) correspond to its regulatory filings.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the doctorgram Stethoscope DES-I and how does it differ from traditional stethoscopes?

    The doctorgram Stethoscope DES-I is designed for auscultation of cardiac and other internal organ sounds, combining traditional stethoscope functionality with digital amplification and recording capabilities. Unlike traditional stethoscopes, it pairs with a smartphone application to enhance diagnostic accuracy by processing and storing audio data digitally, making it ideal for clinical settings where detailed patient records are essential.

  • Is the doctorgram Stethoscope DES-I reusable or single-use, and how should it be maintained?

    The doctorgram Stethoscope DES-I is explicitly described as a reusable device. Since it is not labeled as single-use, proper cleaning and maintenance protocols (e.g., disinfection between patients) should follow clinical guidelines for reusable medical devices to ensure hygiene and longevity. The manufacturer’s instructions (not provided here) would outline specific care details.

  • What regulatory pathway was followed for FDA clearance of the doctorgram Stethoscope DES-I, and what does this mean for clinicians?

    The device received FDA 510(k) clearance under the traditional pathway, classified as Class II with product code DQD (Diagnostic, Cardiovascular). This means the FDA determined it is substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for cardiovascular auscultation. Clinicians can rely on its regulatory review by the Cardiovascular (CV) Advisory Committee for confidence in its design and intended use.

  • Does the doctorgram Stethoscope DES-I require any special handling or safety considerations, such as MRI compatibility?

    The device is explicitly stated to not require MRI safety considerations, meaning it can be safely used in environments where MRI procedures are performed without posing risks to patients or equipment. However, standard precautions for reusable medical devices (e.g., avoiding exposure to extreme temperatures or chemicals) should still be observed.

  • How is the doctorgram Stethoscope DES-I supplied, and what components are included in the package?

    The device is supplied as a reusable stethoscope paired with a smartphone application for data processing and storage. While the exact contents of the packaging aren’t detailed, the core components would include the stethoscope headpiece, tubing, and chestpiece designed for auscultation, along with instructions for pairing with the companion app. The app itself is not a medical device but enables digital functionality for the stethoscope.