510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921595Substantially Equivalent

Y-Type Blood Administration Set Model #Ht-Tr2

Haemotronic, Inc., Fairfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921595 is the FDA 510(k) clearance record for Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2, a class II device, cleared for Haemotronic, Inc. on under FDA product code BRZ (Set, Blood Transfusion). FDA records list 6 510(k) clearances for Haemotronic, Inc., from to . As of , FDA records show no recalls naming K921595.

Clearance record

Decision date
Received
(265 days to decision)
Product code
BRZ Set, Blood Transfusion
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Haemotronic, Inc. 45 Kulick Rd., Fairfield NJ
510(k) summary
Statement
Third party review
No

Clearances, product code BRZ

Trailing 12 months

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

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