510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K030505Substantially Equivalent

Capiox Cardiotomy Reservoir

Terumo Cardiovascular Systems Corporation, Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030505 is the FDA 510(k) clearance record for CAPIOX CARDIOTOMY RESERVOIR, a class II device, cleared for Terumo Cardiovascular Systems Corp. on under FDA product code DPW (Flowmeter, Blood, Cardiovascular). FDA records list 160 510(k) clearances for Terumo Cardiovascular Systems Corp., from to . As of , FDA records show no recalls naming K030505.

Clearance record

Decision date
Received
(84 days to decision)
Product code
DPW Flowmeter, Blood, Cardiovascular
Regulation
21 CFR 870.2100
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Cardiovascular Systems Corp. 125 Blue Ball Rd., Elkton MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPW

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