Cleared Traditional

PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (K010787) - FDA 510(k) Clearance

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

K010787 · Oscor, Inc. · Cardiovascular device
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May 2001
Decision
68d
Days
Class 2
Risk

K010787 is an FDA 510(k) clearance for the PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on May 22, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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 Oscor, Inc. devices

Submission Details

510(k) Number K010787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2001
Decision Date May 22, 2001
Days to Decision 68 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 125d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
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 - DTD Pacemaker Lead Adaptor

All 37
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K010787.
6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP
K132008 · Medtronic, Inc. · Jul 2013
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210 · Medtronic Vascular · Feb 2000
MODEL 2872 BIPOLAR LEAD ADAPTOR KIT
K982220 · Medtronic Vascular · Oct 1998
MODEL 6984M LEAD EXTENDER KIT
K915724 · Medtronic Vascular · Feb 1992
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
K911302 · Medtronic Vascular · Jul 1991
MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT
K910630 · Medtronic Vascular · Apr 1991