Cleared Traditional

MODEL FF..D & FX..D PACEMAKER LEADS (K823896) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K823896 · Dr. Ing. P. Osypka, GmbH · Cardiovascular device
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Apr 1983
Decision
124d
Days
Class 3
Risk

K823896 is an FDA 510(k) clearance for the MODEL FF..D & FX..D PACEMAKER LEADS. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Dr. Ing. P. Osypka, GmbH (Mchenry, US). The FDA issued a Cleared decision on April 30, 1983 after a review of 124 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 Dr. Ing. P. Osypka, GmbH devices

Submission Details

510(k) Number K823896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1982
Decision Date April 30, 1983
Days to Decision 124 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 125d · This submission: 124d
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 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K823896.
LIFELINE TLE 484-02
K843394 · Intermedics, Inc. · Sep 1984
LIFELINE PACING LEADS #471-07 &09
K832409 · Intermedics, Inc. · Aug 1983
MEDTRONIC MODELS 4012 & 4512
K832099 · Medtronic Vascular · Jul 1983
LIFELINE ENDOCARDIAL PACING LEAD #479-05
K830782 · Intermedics, Inc. · Apr 1983
LIFELINE UNIPOLAR J-LEAD #483-05
K830463 · Intermedics, Inc. · Feb 1983
LIFELINE -UNIPOLAR LEAD #487-05
K823508 · Intermedics, Inc. · Jan 1983