Cleared Special

K020669 - PERMANENT PACING LEAD

K020669 is an FDA 510(k) clearance for PERMANENT PACING LEAD, manufactured by Oscor, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Special 510(k) pathway after a 27-day FDA review.

K020669 · Oscor, Inc. · Cardiovascular device
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Mar 2002
Decision
27d
Days
Class 3
Risk

K020669 is an FDA 510(k) clearance for the PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on March 28, 2002 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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, Inc. devices

FDA 510(k) Submission Details - K020669

510(k) Number K020669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date March 28, 2002
Days to Decision 27 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

DTB Device Classification - Class 3, Premarket Approval

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 396
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K020669.
AROX 45-JBP
K023099 · Biotronik, Inc. · Oct 2002
AROX 53-BP
K021217 · Biotronik, Inc. · May 2002
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP
K010281 · Biotronik, Inc. · Apr 2002
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
K013339 · Oscor, Inc. · Nov 2001
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
K003918 · Oscor, Inc. · May 2001
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
K003072 · Biotronik, Inc. · Jan 2001