Cleared Traditional

K872972 - TEMPORARY PACEMAKER ELECTRODE

K872972 is an FDA 510(k) clearance for TEMPORARY PACEMAKER ELECTRODE, manufactured by Oscor Medical Corp.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K872972 · Oscor Medical Corp. · Cardiovascular device
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Dec 1987
Decision
127d
Days
Class 2
Risk

K872972 is an FDA 510(k) clearance for the TEMPORARY PACEMAKER ELECTRODE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Oscor Medical Corp. (Palm Harbor, US). The FDA issued a Cleared decision on December 3, 1987 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 Oscor Medical Corp. devices

FDA 510(k) Submission Details - K872972

510(k) Number K872972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1987
Decision Date December 03, 1987
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 92
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K872972.
TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1
K884866 · Oscor Medical Corp. · Mar 1989
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · C.R. Bard, Inc. · Sep 1988
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
K875059 · Daig Corp. · Feb 1988
DEKNATEL TEMPORARY CARDIAC PACING WIRE
K873728 · Deknatel, Inc. · Nov 1987
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970 · Medtronic Vascular · Sep 1987
TB SERIES BIPOLAR PACING LEADS
K861403 · Oscor Medical Corp. · Jun 1986