Cleared Traditional

K831695 - TEMP. CARDIAC PACING WIRE TME 60/61/65 (FDA 510(k) Clearance)

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

K831695 · Oscor, Inc. · Cardiovascular device
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Oct 1983
Decision
148d
Days
Class 2
Risk

K831695 is an FDA 510(k) clearance for the TEMP. CARDIAC PACING WIRE TME 60/61/65. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on October 20, 1983 after a review of 148 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: Standard predicate-based submission. Standard predicate reliance. 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

Submission Details

510(k) Number K831695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1983
Decision Date October 20, 1983
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 127
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K831695.
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K242705 · Medtronic, Inc. · Jan 2025
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K232261 · Osypka AG · Apr 2024