510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K901281Substantially Equivalent

Thermo Kor-Continuous Pulmonary Artery Thermometer

Val-Mark Medical, Inc., West St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901281 is the FDA 510(k) clearance record for THERMO KOR-CONTINUOUS PULMONARY ARTERY THERMOMETER, a class II device, cleared for Val-Mark Medical, Inc. on under FDA product code DRB (Stylet, Catheter). FDA records list one 510(k) clearance for Val-Mark Medical, Inc. As of , FDA records show no recalls naming K901281.

Clearance record

Decision date
Received
(527 days to decision)
Product code
DRB Stylet, Catheter
Regulation
21 CFR 870.1380
Device class
Class II
Review panel
Cardiovascular
Applicant
Val-Mark Medical, Inc. 115 W. Logan St., West St. Paul MN
Third party review
No

Clearances, product code DRB

Trailing 12 months

FDA records hold no clearances under product code DRB in the trailing twelve months.

FDA records show no clearances under product code DRB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DRB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260