510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K030449Substantially Equivalent

Modification to Capiox Sx10 Hardshell Reservoir

Terumo Corp., Elkton MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030449 is the FDA 510(k) clearance record for MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR, a class II device, cleared for Terumo Corp. on under FDA product code DTN (Reservoir, Blood, Cardiopulmonary Bypass). FDA records list 34 510(k) clearances for Terumo Corp., from to . As of , FDA records show no recalls naming K030449.

Clearance record

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

Clearances, product code DTN

Trailing 12 months
1 clearance under product code DTN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260