Cleared Traditional

EXTERNAL DEMAND PACEMAKER (K923621) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 19
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K923621.
Medtronic Model 5392 External Pulse Generator (EPG)
K150246 · Medtronic, Inc. · Feb 2015
MEDTRONIC EXTERNAL PULSE GENERATOR (EPG)
K132924 · Medtronic, Inc. · Oct 2013
MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL
K971474 · Medtronic Vascular · Jul 1997
MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR
K910237 · Medtronic Vascular · Feb 1991
MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE
K893633 · Medtronic Vascular · Jun 1989
PACING SYSTEM ANALYZER
K803313 · Medtronic Vascular · Feb 1981