510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973741Substantially Equivalent

Bair Hugger Blood/fluid Warmer

Augustine Medical, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973741 is the FDA 510(k) clearance record for BAIR HUGGER BLOOD/FLUID WARMER, a class II device, cleared for Augustine Medical, Inc. on under FDA product code BSB (Warmer, Blood, Non-Electromagnetic Radiation). FDA records list 25 510(k) clearances for Augustine Medical, Inc., from to . As of , FDA records show 3 recalls naming K973741.

Clearance record

Decision date
Received
(211 days to decision)
Product code
BSB Warmer, Blood, Non-Electromagnetic Radiation
Regulation
21 CFR 864.9205
Device class
Class II
Review panel
Hematology
Applicant
Augustine Medical, Inc. 10393 W. 70th St., Eden Prairie MN
510(k) summary
Summary
Third party review
No

Clearances, product code BSB

Trailing 12 months

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

FDA records show no clearances under product code BSB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSB, 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