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

Toa Medical Electronics USA, Inc. · Predicate Candidate Screening

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

81 daysmedian FDA review time

149 days90th percentile

33clearances measured

K-number	Device	Applicant	Decided	Review days
K936023	SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER	Toa Medical Electronics USA, Inc.	1994-05-02	138
K933886	TOA MEDICAL ELECTRONICS CA-5000	Toa Medical Electronics USA, Inc.	1994-01-27	170
K931149	CA-1000 AUTOMATED COAGULATION ANALYZER	Toa Medical Electronics USA, Inc.	1993-11-03	240
K920544	SYSMEX HEMATOLOGY SYSTEM ACCESSORIES	Toa Medical Electronics USA, Inc.	1992-04-29	83
K914744	SYSMEX NE-1500, MODIFICATION	Toa Medical Electronics USA, Inc.	1991-12-30	69
K912494	SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER	Toa Medical Electronics USA, Inc.	1991-09-10	97
K911173	SYSMEX F-310	Toa Medical Electronics USA, Inc.	1991-07-26	149
K911172	SYSMEX F-610	Toa Medical Electronics USA, Inc.	1991-07-26	149
K910849	SYSMEX F-810	Toa Medical Electronics USA, Inc.	1991-07-26	149
K910745	HEMOGLOBIN REAGENT	Toa Medical Electronics USA, Inc.	1991-07-11	140
K894539	SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER	Toa Medical Electronics USA, Inc.	1989-09-26	68
K883997	SYSMEX NE-8000	Toa Medical Electronics USA, Inc.	1988-12-05	76
K882370	SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER	Toa Medical Electronics USA, Inc.	1988-08-25	78
K882767	SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM	Toa Medical Electronics USA, Inc.	1988-07-18	12
K882267	SYSMEX QUICKLYSER-II (QLS-200A)	Toa Medical Electronics USA, Inc.	1988-07-12	42
K873734	SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER	Toa Medical Electronics USA, Inc.	1987-11-25	71
K871600	SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.	Toa Medical Electronics USA, Inc.	1987-06-24	61
K855117	SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM	Toa Medical Electronics USA, Inc.	1986-02-24	63
K855116	SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM	Toa Medical Electronics USA, Inc.	1986-02-24	63
K850354	SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS	Toa Medical Electronics USA, Inc.	1985-05-20	110
K850171	SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS	Toa Medical Electronics USA, Inc.	1985-05-13	117
K850239	SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-	Toa Medical Electronics USA, Inc.	1985-04-01	69
K844910	SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -	Toa Medical Electronics USA, Inc.	1985-04-01	104
K834021	SYSMEX CC-780 EIGHT PARAMETER AUT0	Toa Medical Electronics USA, Inc.	1984-03-02	101
K830507	SYSMEX CC-170	Toa Medical Electronics USA, Inc.	1983-05-13	85
K830505	SYSMEX CC-130	Toa Medical Electronics USA, Inc.	1983-05-09	81
K830506	SYSMEX CC-150	Toa Medical Electronics USA, Inc.	1983-05-09	81
K830508	SYSMEX CC-180	Toa Medical Electronics USA, Inc.	1983-05-09	81
K822758	SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY	Toa Medical Electronics USA, Inc.	1982-10-18	34
K780911	SYSMEX PLATELET COUNTER, PL-110	Toa Medical Electronics USA, Inc.	1978-06-28	27
K780910	SYSTEM AUTO. BLOOD CELL COUNTER CC-110	Toa Medical Electronics USA, Inc.	1978-06-28	27
K780909	SYSMEX AUTO. BLOOD CELL COUNTER, CC-120	Toa Medical Electronics USA, Inc.	1978-06-28	27
K780224	MICROCELL COUNTER MODEL CC-108	Toa Medical Electronics USA, Inc.	1978-05-19	105

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