Cleared Traditional

K961857 - LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060

K961857 is an FDA 510(k) clearance for LABTRON ELECTROMAX ELECTRONIC STETHOSCO..., manufactured by Graham-Field, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K961857 · Graham-Field, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
50d
Days
Class 2
Risk

K961857 is an FDA 510(k) clearance for the LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Graham-Field, Inc. (Great Neck,, US). The FDA issued a Cleared decision on July 3, 1996 after a review of 50 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 Graham-Field, Inc. devices

FDA 510(k) Submission Details - K961857

510(k) Number K961857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1996
Decision Date July 03, 1996
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
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 63
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K961857.
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K003723 · 3M Company · Mar 2001
3M LITTMANN GRAPHIC DISPLAY SYSTEM
K920009 · 3M Health Care, Ltd. · Oct 1992
MASCOT STETHOSCOPE PROBE
K874726 · Imex Medical Systems, Inc. · Mar 1988
DIF-STET
K832882 · Intersect Systems, Inc. · Dec 1983