Cleared Traditional

K832882 - DIF-STET

K832882 is an FDA 510(k) clearance for DIF-STET, manufactured by Intersect Systems, Inc.. The device is a Class 2 Cardiovascular device with 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.

FDA 510(k) Submission Details - K832882

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
Combination Product No
PCCP Authorized No
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.

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 156
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K832882.
LIFESOUND - ELECTRONIC STETHOSCOPE
K844804 · Biomedical Concepts, Inc. · Feb 1985
MX2 ELECTRONIC STETHOSCOPE
K842705 · Medmax, Inc. · Jan 1985
MAX I
K831763 · Trade Max, Inc. · Jan 1984
ELECTRONIC STETHOSCOPE #S-50
K812148 · Syphgmostat · Aug 1981
CONPHAR SUPERTONE STETHOSCOPE
K801189 · Conphar, Inc. · Jun 1980
HYPERSTETHOSCOPE, MODEL Z 00
K801165 · Demonbinder Electronics · May 1980
K832882 · DIF-STET
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