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

Terumo America, Inc. · Predicate Candidate Screening

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

35 daysmedian FDA review time

103 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K811523	PLASMA FLEX	Terumo America, Inc.	1981-09-09	103	0
K802970	TERUMO HOLLOW FIBER OXYGENATOR	Terumo America, Inc.	1981-01-22	62	0
K802441	CLIRANS TH10 HOLLOW FIBER DIALYZER	Terumo America, Inc.	1980-12-18	72	0
K802122	CLIRANS TH13 HOLLOW FIBER DIALYZER	Terumo America, Inc.	1980-12-18	105	0
K801192	CLIRANS TE10 HOLLOW FIBER DIALYZER	Terumo America, Inc.	1980-08-12	85	0
K801194	CLIRANS TE07 HOLLOW FIBER DIALYZER	Terumo America, Inc.	1980-08-12	85	0
K801193	CLIRANS TE15 HOLLOW FIBER DIALYZER	Terumo America, Inc.	1980-08-12	85	0
K791411	COAXIAL DUAL FLOW CATHETER	Terumo America, Inc.	1979-11-13	109	0
K791173	SURFLO INJECTION PLUG	Terumo America, Inc.	1979-07-30	35	0
K790105	TERUMO IMUGARD	Terumo America, Inc.	1979-05-24	128	0
K772362	AVF SET FOR SINGLE NEEDLE HEMODIALYSIS	Terumo America, Inc.	1978-03-17	80	0
K772040	TRANSDUCER PROTECTOR	Terumo America, Inc.	1977-11-28	31	0
K771432	HICALIQ IVH BAG	Terumo America, Inc.	1977-09-28	58	0
K771431	ARTIFICIAL K-NOSE BREATHAID	Terumo America, Inc.	1977-09-28	58	0
K771693	CLIRANS BLOOD LINES SET	Terumo America, Inc.	1977-09-20	14	0
K771430	BLOOD FILTER, W/SET	Terumo America, Inc.	1977-09-20	50	0
K771694	CLIRANS TH 15 HOLLOW FIBER DIALYZER	Terumo America, Inc.	1977-09-15	9	0
K771212	SAFEED DISP. PLASTIC CATHETER	Terumo America, Inc.	1977-09-12	69	0
K771458	INFUSION ACCELERATOR	Terumo America, Inc.	1977-08-26	22	0
K771454	MICRO SYRINGE & NEEDLE	Terumo America, Inc.	1977-08-16	12	0
K771209	TERUFUSION BLOOD ADMIN. SET	Terumo America, Inc.	1977-07-26	21	0
K771206	AV FISTULA NEEDLE SET	Terumo America, Inc.	1977-07-15	10	0
K771211	DOPPLER (UTD-5 & UTD-6)	Terumo America, Inc.	1977-07-14	9	0
K771204	SURFLO WINGED INFUSION SET	Terumo America, Inc.	1977-07-14	9	0
K771207	TERUFUSION DONOR SET	Terumo America, Inc.	1977-07-14	9	0
K771203	DISP. HYPODERMIC NEEDLE	Terumo America, Inc.	1977-07-14	9	1
K771205	HYPODERMIC SYRINGE	Terumo America, Inc.	1977-07-14	9	0
K771210	UROGARD URINARY DRAINAGE BAG	Terumo America, Inc.	1977-07-11	6	0
K770422	CATHETER, SURFLO, I.V.	Terumo America, Inc.	1977-03-16	9	0
K760948	THERMO FINER CORETEMP	Terumo America, Inc.	1976-12-09	38	0
K760775	TERUMO DISPOSABLE SPINAL NEEDLE	Terumo America, Inc.	1976-11-01	28	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