Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Terumo Corp. — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

39 daysmedian FDA review time

160 days90th percentile

21clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K100282	TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER	Terumo Corp.	2010-02-26	25	0
K092372	HEARTRAIL III GUIDING CATHETER	Terumo Corp.	2009-09-11	37	0
K091417	SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240	Terumo Corp.	2009-05-22	9	0
K090973	TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51	Terumo Corp.	2009-05-01	25	0
K073474	CAPIOX CIRCUIT CONNECTORS	Terumo Corp.	2008-03-05	85	0
K071572	CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL	Terumo Corp.	2007-07-23	45	0
K071494	CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FI	Terumo Corp.	2007-07-16	47	12
K071075	TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A	Terumo Corp.	2007-05-25	39	0
K040783	FOUNDATION	Terumo Corp.	2004-10-13	201	0
K040210	CAPIOX RX25 HOLLOW FIBER OXYGENATOR W/WO HARDSHELL RESERVOIR	Terumo Corp.	2004-03-03	33	0
K033681	GLIDESHEATH	Terumo Corp.	2003-12-11	17	0
K031266	SURSHIELD SAFETY WINGED INFUSION SET	Terumo Corp.	2003-05-30	39	0
K030449	MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR	Terumo Corp.	2003-03-05	22	0
K022115	CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESE	Terumo Corp.	2002-09-27	88	0
K003371	PUMP TUBING WITH X-COATING	Terumo Corp.	2000-12-21	52	0
K993189	CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIO	Terumo Corp.	2000-03-01	160	0
K983490	TERUMO VENOJECT,LUER ADAPTER	Terumo Corp.	1998-11-30	56	0
K980796	TERUMO ALLERGY SYRINGE	Terumo Corp.	1998-04-02	31	0
K943861	CAPIOX SP PUMP HEAD	Terumo Corp.	1995-08-15	372	0
K910969	TORQUE DEVICE FOR A GUIDE WIRE	Terumo Corp.	1991-05-16	71	0
K910722	450CM GUIDE WIRE FOR G.I. USE	Terumo Corp.	1991-03-21	29	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda