510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K882501Substantially Equivalent

Accufibrin(tm) Blood Collection System Af100

Terumo Medical Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882501 is the FDA 510(k) clearance record for ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100, a class II device, cleared for Terumo Medical Corp. on under FDA product code GIM (Tubes, Vacuum Sample, With Anticoagulant). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K882501.

Clearance record

Decision date
Received
(31 days to decision)
Product code
GIM Tubes, Vacuum Sample, With Anticoagulant
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
Third party review
No

Clearances, product code GIM

Trailing 12 months

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

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