510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K961000Substantially Equivalent

Capiox Sx18 Hollow Fiber Oxygenator with and without Detachable Hardshell Reservoir

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

K961000 is the FDA 510(k) clearance record for CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR, a class II device, cleared for Terumo Medical Corp. on under FDA product code DTZ (Oxygenator, Cardiopulmonary Bypass). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K961000.

Clearance record

Decision date
Received
(204 days to decision)
Product code
DTZ Oxygenator, Cardiopulmonary Bypass
Regulation
21 CFR 870.4350
Device class
Class II
Review panel
Cardiovascular
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
510(k) summary
Summary
Third party review
No

Clearances, product code DTZ

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