Cleared Traditional

K832882 - DIF-STET

K832882 is the FDA 510(k) clearance for DIF-STET by Intersect Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQD) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K832882 · Intersect Systems, Inc. · Cardiovascular device
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Dec 1983
Decision
102d
Days
Class 2
Risk

K832882 is an FDA 510(k) clearance for the DIF-STET. Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Intersect Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1983 after a review of 102 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 Intersect Systems, Inc. devices

Submission Details

510(k) Number K832882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1983
Decision Date December 06, 1983
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
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 59
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K832882.
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