Cleared Traditional

K844804 - LIFESOUND - ELECTRONIC STETHOSCOPE

K844804 is the FDA 510(k) clearance for LIFESOUND - ELECTRONIC STETHOSCOPE by Biomedical Concepts, Inc.. It is a Class 2 Cardiovascular device (product code DQD) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K844804 · Biomedical Concepts, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
64d
Days
Class 2
Risk

K844804 is an FDA 510(k) clearance for the LIFESOUND - ELECTRONIC STETHOSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Biomedical Concepts, Inc. (White Plans, US). The FDA issued a Cleared decision on February 13, 1985 after a review of 64 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 Biomedical Concepts, Inc. devices

Submission Details

510(k) Number K844804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1984
Decision Date February 13, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
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 K844804.
MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K050159 · 3M Company · Feb 2005
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K041934 · 3M Company · Oct 2004
3M LITTMANN
K003723 · 3M Company · Mar 2001
CONPHAR SUPERTONE STETHOSCOPE
K801189 · Conphar, Inc. · Jun 1980
CONPHAR STETHSCOPE
K792112 · Conphar, Inc. · Dec 1979
ELECTRONIC STETHOSCOPE
K771653 · 3M Company · Sep 1977