Cleared Traditional

K925143 - MODEL 4800 ACCUPACE PACING SYSTEM ANALYER

K925143 is an FDA 510(k) clearance for MODEL 4800 ACCUPACE PACING SYSTEM ANALYER, 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 714-day FDA review.

K925143 · Pace Medical · Cardiovascular device
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Sep 1994
Decision
714d
Days
Class 2
Risk

K925143 is an FDA 510(k) clearance for the MODEL 4800 ACCUPACE PACING SYSTEM ANALYER. 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 September 27, 1994 after a review of 714 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Pace Medical devices

FDA 510(k) Submission Details - K925143

510(k) Number K925143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1992
Decision Date September 27, 1994
Days to Decision 714 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
589d slower than avg
Panel avg: 125d · This submission: 714d
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 K925143.
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