Cleared Traditional

K900982 - E-CLIP

K900982 is an FDA 510(k) clearance for E-CLIP, manufactured by Joel Cohen & Esther R. Cohen. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K900982 · Joel Cohen & Esther R. Cohen · Cardiovascular device
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Apr 1990
Decision
48d
Days
Class 2
Risk

K900982 is an FDA 510(k) clearance for the E-CLIP. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Joel Cohen & Esther R. Cohen (Plantation, US). The FDA issued a Cleared decision on April 19, 1990 after a review of 48 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. 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 Joel Cohen & Esther R. Cohen devices

FDA 510(k) Submission Details - K900982

510(k) Number K900982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1990
Decision Date April 19, 1990
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

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 96
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K900982.
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UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789 · Medtronic Vascular · Dec 1989
MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE
K890988 · Pace Medical · Aug 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
K890794 · Daig Corp. · Jun 1989