510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K812659Substantially Equivalent

Terumo Hollow Oxygenator Circuit

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

K812659 is the FDA 510(k) clearance record for TERUMO HOLLOW OXYGENATOR CIRCUIT, a class II device, cleared for Terumo Medical Corp. on under FDA product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K812659.

Clearance record

Decision date
Received
(87 days to decision)
Product code
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Regulation
21 CFR 870.4260
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
Third party review
No

Clearances, product code DTM

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