Cleared Traditional

PACEMAKER ELECTRODE INSERTER AIDE (K800088) - FDA 510(k) Clearance

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

K800088 · Telectronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1980
Decision
15d
Days
Class 2
Risk

K800088 is an FDA 510(k) clearance for the PACEMAKER ELECTRODE INSERTER AIDE. Classified as Pulse-generator, Pacemaker, External (product code DTE), Class II - Special Controls.

Submitted by Telectronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 29, 1980 after a review of 15 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 Telectronics, Inc. devices

Submission Details

510(k) Number K800088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1980
Decision Date January 29, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
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 K800088.
PACING SYSTEM ANALYZER
K803313 · Medtronic Vascular · Feb 1981
CHRONOCOR IV MODEL 250
K802221 · Cordis Corp. · Nov 1980
COMPUPACE, 524-01 PACER SYSTEM COMPUTER
K801055 · Intermedics, Inc. · Oct 1980
MEDTRONIC MODEL 546
K782108 · Medtronic Vascular · Dec 1978
PULSE GENERATOR, MODEL 240, EXTERNAL
K781327 · Intermedics, Inc. · Dec 1978