Cleared Traditional

K823891 - MODEL KY PACEMAKER LEAD - VARIOUS

K823891 is an FDA 510(k) clearance for MODEL KY PACEMAKER LEAD - VARIOUS, manufactured by Oscor, Inc.. The device is a Class 3 Cardiovascular device with product code DTB cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K823891 · Oscor, Inc. · Cardiovascular device
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Mar 1983
Decision
94d
Days
Class 3
Risk

K823891 is an FDA 510(k) clearance for the MODEL KY PACEMAKER LEAD - VARIOUS. 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 31, 1983 after a review of 94 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: 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 - K823891

510(k) Number K823891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1982
Decision Date March 31, 1983
Days to Decision 94 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
31d faster than avg
Panel avg: 125d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

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 K823891.
LIFELINE ENDOCARDIAL PACING LEAD #479-05
K830782 · Intermedics, Inc. · Apr 1983
VASCULAR PRODUCTS IMPLANTABLE PACING
K830950 · Oscor, Inc. · Apr 1983
MODEL ZY PACEMAKER LEAD-VARIOUS
K823890 · Oscor, Inc. · Mar 1983
PACING LEAD #PMA F 860
K830457 · Ela Medical, Inc. · Mar 1983
PACEMAKER ELECTRODE PERM. & TEMP
K830464 · Daig Corp. · Mar 1983
LIFELINE UNIPOLAR J-LEAD #483-05
K830463 · Intermedics, Inc. · Feb 1983