Cleared Traditional

K915008 - PERMANENT PACING PAD

K915008 is the FDA 510(k) clearance for PERMANENT PACING PAD by Oscor Medical Corp.. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K915008 · Oscor Medical Corp. · Cardiovascular device
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Jan 1992
Decision
84d
Days
Class 3
Risk

K915008 is an FDA 510(k) clearance for the PERMANENT PACING PAD, MODIFICATION. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Oscor Medical Corp. (Palm Harbor, US). The FDA issued a Cleared decision on January 27, 1992 after a review of 84 days - a notably fast clearance cycle.

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: High-complexity regulatory submission. High regulatory complexity profile. 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

Submission Details

510(k) Number K915008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1991
Decision Date January 27, 1992
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 386
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K915008.
PERMANENT CARDIAC PACING LEADS AND ADAPTORS
K912464 · Medtronic Vascular · Feb 1992
OSCOR MEDICAL CORP PERMANENT PACING LEAD
K912867 · Oscor Medical Corp. · Feb 1992
PERMANENT PACING LEADS, MODIFICATION
K915007 · Oscor Medical Corp. · Jan 1992
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS
K913288 · Medtronic Vascular · Oct 1991
MODIFIED OSCOR PY PACING LEADS/MODIFICATION
K913158 · Oscor Medical Corp. · Sep 1991
PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION
K913201 · Oscor Medical Corp. · Sep 1991