510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760012Substantially Equivalent

Blood Warmer (Code 4R4305)

Travenol Laboratories, S.A., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760012 is the FDA 510(k) clearance record for BLOOD WARMER (CODE 4R4305), a class II device, cleared for Travenol Laboratories, S.A. on under FDA product code BSB (Warmer, Blood, Non-Electromagnetic Radiation). FDA records list 206 510(k) clearances for Travenol Laboratories, S.A., from to . As of , FDA records show no recalls naming K760012.

Clearance record

Decision date
Received
(36 days to decision)
Product code
BSB Warmer, Blood, Non-Electromagnetic Radiation
Regulation
21 CFR 864.9205
Device class
Class II
Review panel
Hematology
Applicant
Travenol Laboratories, S.A. 803 N. Front St. Suite 3, Mchenry IL
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