510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894664Substantially Equivalent

Capiox Hardshell Venous Reservoir

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

K894664 is the FDA 510(k) clearance record for CAPIOX HARDSHELL VENOUS RESERVOIR, a class II device, cleared for Terumo Medical Corp. on under FDA product code DTN (Reservoir, Blood, Cardiopulmonary Bypass). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K894664.

Clearance record

Decision date
Received
(270 days to decision)
Product code
DTN Reservoir, Blood, Cardiopulmonary Bypass
Regulation
21 CFR 870.4400
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
Third party review
No

Clearances, product code DTN

Trailing 12 months
1 clearance under product code DTN in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTN, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260