Cleared Traditional

HEART STG SYSTEM AND SOFTWARE (K052283) - FDA 510(k) Clearance

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

K052283 · Stethographics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
123d
Days
Class 2
Risk

K052283 is an FDA 510(k) clearance for the HEART STG SYSTEM AND SOFTWARE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Stethographics, Inc. (Boston, US). The FDA issued a Cleared decision on December 23, 2005 after a review of 123 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 Stethographics, Inc. devices

Submission Details

510(k) Number K052283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2005
Decision Date December 23, 2005
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 125d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - DQD Stethoscope, Electronic

All 54
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K052283.
Electronic Stethoscope DS3011A
K173663 · Imediplus, Inc. · Aug 2018
CliniCloud Stethoscope
K173448 · Stethocloud Pty.Ltd (Clinicloud) · Jan 2018
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200
K083903 · 3M Company · Jul 2009
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100
K051790 · 3M Company · Jul 2005
MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K050159 · 3M Company · Feb 2005
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K041934 · 3M Company · Oct 2004