510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K770253Substantially Equivalent

Microfiltration Set Mf10

Biotest-Serum-Institut, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K770253 is the FDA 510(k) clearance record for MICROFILTRATION SET MF10, a class II device, cleared for Biotest-Serum-Institut on under FDA product code CAK (Microfilter, Blood Transfusion). FDA records list 2 510(k) clearances for Biotest-Serum-Institut, from to . As of , FDA records show no recalls naming K770253.

Clearance record

Decision date
Received
(55 days to decision)
Product code
CAK Microfilter, Blood Transfusion
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Biotest-Serum-Institut 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

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