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
K813001Substantially Equivalent

Fibri-Filter 20

Tri-Med, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813001 is the FDA 510(k) clearance record for FIBRI-FILTER 20, a class II device, cleared for Tri-Med, Inc. on under FDA product code FPB (Filter, Infusion Line). FDA records list 29 510(k) clearances for Tri-Med, Inc., from to . As of , FDA records show no recalls naming K813001.

Clearance record

Decision date
Received
(11 days to decision)
Product code
FPB Filter, Infusion Line
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Tri-Med, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FPB

Trailing 12 months
1 clearance under product code FPB in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260