Cleared Traditional

K821791 - EXTERNAL PULSE GENERATOR - EV4542

K821791 is an FDA 510(k) clearance for EXTERNAL PULSE GENERATOR - EV4542, manufactured by American Pacemaker Corp.. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K821791 · American Pacemaker Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1982
Decision
19d
Days
Class 2
Risk

K821791 is an FDA 510(k) clearance for the EXTERNAL PULSE GENERATOR - EV4542. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by American Pacemaker Corp. (Walker, US). The FDA issued a Cleared decision on July 6, 1982 after a review of 19 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Pacemaker Corp. devices

FDA 510(k) Submission Details - K821791

510(k) Number K821791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1982
Decision Date July 06, 1982
Days to Decision 19 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 125d · This submission: 19d
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 55
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K821791.
EXTERNAL PULSE GENERATOR FOR TEMP. STIM
K831768 · Oscor, Inc. · Dec 1983
RAPID ATRIAL PACER
K831381 · Seamed Corp. · Aug 1983
SEA MED MODEL 880
K823048 · Seamed Corp. · Dec 1982
SEAMED, #540 - SIEMENS, #146F TELECTRO
K820570 · Seamed Corp. · Jun 1982
STERILE PACKAGING
K811092 · Telectronics, Inc. · Jul 1981
PACING SYSTEM ANALYZER
K803313 · Medtronic Vascular · Feb 1981