Cleared Traditional

K860994 - DECITEL AUSCULSCOPE

K860994 is an FDA 510(k) clearance for DECITEL AUSCULSCOPE, manufactured by Bloomfield Research and Development, Inc.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K860994 · Bloomfield Research and Development, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1986
Decision
235d
Days
Class 2
Risk

K860994 is an FDA 510(k) clearance for the DECITEL AUSCULSCOPE. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Bloomfield Research and Development, Inc. (Hilton Head, US). The FDA issued a Cleared decision on November 7, 1986 after a review of 235 days - an extended review 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: 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 Bloomfield Research and Development, Inc. devices

FDA 510(k) Submission Details - K860994

510(k) Number K860994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1986
Decision Date November 07, 1986
Days to Decision 235 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 125d · This submission: 235d
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 59
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K860994.
ADC 656 ELECTRONIC STETHOSCOPE
K012304 · American Diagnostic Corp. · Nov 2001
3M LITTMANN
K003723 · 3M Company · Mar 2001
3M LITTMANN GRAPHIC DISPLAY SYSTEM
K920009 · 3M Health Care, Ltd. · Oct 1992
CONPHAR SUPERTONE STETHOSCOPE
K801189 · Conphar, Inc. · Jun 1980
CONPHAR STETHSCOPE
K792112 · Conphar, Inc. · Dec 1979
ELECTRONIC STETHOSCOPE
K771653 · 3M Company · Sep 1977