Cleared Traditional

K850622 - OSCOR MEDICAL MODEL TME 64S BIPOLAR TEM...

K850622 is the FDA 510(k) clearance for OSCOR MEDICAL MODEL TME 64S BIPOLAR TEM... by Oscor Medical Corp.. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K850622 · Oscor Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
50d
Days
Class 2
Risk

K850622 is an FDA 510(k) clearance for the OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Oscor Medical Corp. (Washington, US). The FDA issued a Cleared decision on April 10, 1985 after a review of 50 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 Oscor Medical Corp. devices

Submission Details

510(k) Number K850622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date April 10, 1985
Days to Decision 50 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
75d faster than avg
Panel avg: 125d · This submission: 50d
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 81
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K850622.
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513 · C.R. Bard, Inc. · Sep 1985
NUMED TEMP. STYLET PACING PAROBE 1318694
K851845 · NuMED, Inc. · Aug 1985
NUMED BALLOON PACING CATHETER
K851246 · NuMED, Inc. · Apr 1985
ELECATH OPEN TIP BIPOLAR PACING CATHETER
K850324 · Electro-Catheter Corp. · Mar 1985
NUMED BALLOON PACING CATHETER
K843290 · NuMED, Inc. · Jan 1985
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
K844003 · Electro-Catheter Corp. · Dec 1984