Cleared Traditional

THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER (K901281) - FDA 510(k) Clearance

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

K901281 · Val-Mark Medical, Inc. · Cardiovascular device
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Aug 1991
Decision
527d
Days
Class 2
Risk

K901281 is an FDA 510(k) clearance for the THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER. Classified as Stylet, Catheter (product code DRB), Class II - Special Controls.

Submitted by Val-Mark Medical, Inc. (West St. Paul, US). The FDA issued a Cleared decision on August 28, 1991 after a review of 527 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1380 - 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. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Val-Mark Medical, Inc. devices

Submission Details

510(k) Number K901281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1990
Decision Date August 28, 1991
Days to Decision 527 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
402d slower than avg
Panel avg: 125d · This submission: 527d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRB Stylet, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1380
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 - DRB Stylet, Catheter

All 9
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K901281.
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular · Apr 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular · Feb 2001
PLACER MODEL 6232 STEERABLE STYLET
K000955 · Medtronic Vascular · Jun 2000
TUNNELING STYLET
K882097 · Quinton, Inc. · Jul 1988
OBTURATOR
K770404 · Abbott Laboratories · Mar 1977