510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061103Substantially Equivalent

Haemonetics 40U Rbc Filter Bag

Haemonetics Corporation, Braintree MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K061103 is the FDA 510(k) clearance record for HAEMONETICS 40U RBC FILTER BAG, a class II device, cleared for Haemonetics Corp. on under FDA product code CAK (Microfilter, Blood Transfusion). FDA records list 36 510(k) clearances for Haemonetics Corp., from to . As of , FDA records show no recalls naming K061103.

Clearance record

Decision date
Received
(27 days to decision)
Product code
CAK Microfilter, Blood Transfusion
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Haemonetics Corp. 400 Wood Rd., Braintree MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code CAK

Trailing 12 months

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

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