Cleared Traditional

K023637 - TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)

K023637 is an FDA 510(k) clearance for TYTAN ELECTRONIC STETHOSCOPES (MODEL #600), manufactured by Tytan Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K023637 · Tytan Medical Corp. · Cardiovascular device
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Feb 2003
Decision
119d
Days
Class 2
Risk

K023637 is an FDA 510(k) clearance for the TYTAN ELECTRONIC STETHOSCOPES (MODEL #600). Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by Tytan Medical Corp. (Flagstaff, US). The FDA issued a Cleared decision on February 26, 2003 after a review of 119 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 Tytan Medical Corp. devices

FDA 510(k) Submission Details - K023637

510(k) Number K023637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2002
Decision Date February 26, 2003
Days to Decision 119 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
6d faster than avg
Panel avg: 125d · This submission: 119d
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 106
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K023637.
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