Cleared Traditional

K870323 - MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER

K870323 is an FDA 510(k) clearance for MODEL EV4543 MINIATURE TEMPORARY CARDIA..., manufactured by Pace Medical. The device is a Class 2 Cardiovascular device with product code DTE cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K870323 · Pace Medical · Cardiovascular device
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Mar 1987
Decision
34d
Days
Class 2
Risk

K870323 is an FDA 510(k) clearance for the MODEL EV4543 MINIATURE TEMPORARY CARDIAC PACEMAKER. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Pace Medical (Waltham, US). The FDA issued a Cleared decision on March 3, 1987 after a review of 34 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 Pace Medical devices

FDA 510(k) Submission Details - K870323

510(k) Number K870323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date March 03, 1987
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
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 K870323.
SEAMED MODEL 3200
K872551 · Seamed Corp. · Jul 1987
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ERA-20
K853194 · Biotronik Sales, Inc. · Mar 1987
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K854648 · Seamed Corp. · Jan 1986
CHRONOCOR V EXTERNAL PACER, MODEL 297A
K850822 · Seamed Corp. · Jul 1985