Cleared Traditional

K812999 - PET POLYETHYLENE TORQUE CATHETER

K812999 is the FDA 510(k) clearance for PET POLYETHYLENE TORQUE CATHETER by Universal Medical Instrument Corp.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K812999 · Universal Medical Instrument Corp. · Cardiovascular device
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Nov 1981
Decision
21d
Days
Class 2
Risk

K812999 is an FDA 510(k) clearance for the PET POLYETHYLENE TORQUE CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Universal Medical Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Universal Medical Instrument Corp. devices

Submission Details

510(k) Number K812999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1981
Decision Date November 16, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 293
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K812999.
ANGIOGRAPHIC CATHETER
K821816 · Medi-Tech, Inc. · Aug 1982
ANGIOGRAPHY KIT
K821976 · Mallinckrodt Critical Care · Jul 1982
CORONARY INFUSION KIT
K820001 · Mallinckrodt Critical Care · Jan 1982
GANZ CORONARY REPERFUSION CATHETER
K803270 · American Edwards Laboratories · Mar 1981
BAIM TM CORONARY SINUS FLOW THERMAL
K810360 · Electro-Catheter Corp. · Mar 1981
USCI CARDIOVASCULAR CATHETER
K810412 · C.R. Bard, Inc. · Mar 1981