Cleared Traditional

K923621 - EXTERNAL DEMAND PACEMAKER

K923621 is an FDA 510(k) clearance for EXTERNAL DEMAND PACEMAKER, manufactured by Oscor Medical Corp.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K923621 · Oscor Medical Corp. · Cardiovascular device
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May 1993
Decision
302d
Days
Class 2
Risk

K923621 is an FDA 510(k) clearance for the EXTERNAL DEMAND PACEMAKER. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Oscor Medical Corp. (Palm Harbor, US). The FDA issued a Cleared decision on May 19, 1993 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3600 - 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. Elevated predicate reliance profile. 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 Oscor Medical Corp. devices

FDA 510(k) Submission Details - K923621

510(k) Number K923621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date May 19, 1993
Days to Decision 302 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
177d slower than avg
Panel avg: 125d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTE Device Classification - Class 2, Special Controls

Product Code DTE Pulse-generator, Pacemaker, External
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3600
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 - DTE Pulse-generator, Pacemaker, External

All 54
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K923621.
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K913805 · Pace Medical · Nov 1991