Cleared Traditional

COMPUPACE, 524-01 PACER SYSTEM COMPUTER (K801055) - FDA 510(k) Clearance

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

K801055 · Intermedics, Inc. · Cardiovascular device
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Oct 1980
Decision
178d
Days
Class 2
Risk

K801055 is an FDA 510(k) clearance for the COMPUPACE, 524-01 PACER SYSTEM COMPUTER. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 178 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Intermedics, Inc. devices

Submission Details

510(k) Number K801055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1980
Decision Date October 31, 1980
Days to Decision 178 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
53d slower than avg
Panel avg: 125d · This submission: 178d
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 21
Devices cleared under the same product code (DTE) and FDA review panel - the closest regulatory comparables to K801055.
STERILE PACKAGING
K811092 · Telectronics, Inc. · Jul 1981
PACING SYSTEM ANALYZER
K803313 · Medtronic Vascular · Feb 1981
CHRONOCOR IV MODEL 250
K802221 · Cordis Corp. · Nov 1980
EXTERNAL, TEMP. PORTABLE CARDIAC GENER
K801953 · Telectronics, Inc. · Oct 1980
PACEMAKER ELECTRODE INSERTER AIDE
K800088 · Telectronics, Inc. · Jan 1980
MEDTRONIC MODEL 546
K782108 · Medtronic Vascular · Dec 1978