Cleared Traditional

K901281 - THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER

K901281 is an FDA 510(k) clearance for THERMO KOR-CONTINUOUS PULMONARY ARTERY ..., manufactured by Val-Mark Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRB cleared through the Traditional 510(k) pathway after a 527-day FDA review.

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

FDA 510(k) Submission Details - K901281

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.

DRB Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (DRB) and FDA review panel - the closest regulatory comparables to K901281.
LEAD STYLET,MODELS 6505,6506,6507,6508
K992863 · Guidant Corp. · Nov 1999
SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
K990713 · Spectranetics Corp. · Oct 1999
TARGET THERAPEUTICS RADIOPAQUE STYLET
K914001 · Target Therapeutics · Nov 1991
LEAD STYLET
K905674 · Cardiac Pacemakers, Inc. · Jan 1991
TUNNELING STYLET
K882097 · Quinton, Inc. · Jul 1988
STIFF STYLETS
K802076 · Cardiac Pacemakers, Inc. · Sep 1980