510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854566Substantially Equivalent

Terumo Surflo Etfe i.v. Catheter

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

K854566 is the FDA 510(k) clearance record for TERUMO SURFLO ETFE I.V. CATHETER, a class II device, cleared for Terumo Medical Corp. on under FDA product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K854566.

Clearance record

Decision date
Received
(79 days to decision)
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
Third party review
No

Clearances, product code FOZ

Trailing 12 months
9 clearances under product code FOZ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FOZ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20262
May 20261
June 20260
July 20262
August 20261
September 20261
October 20260