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

Tosoh Medics, Inc. — Predicate Candidate Screening

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

91 daysmedian FDA review time

171 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K023893	ST AIA-PACK CEA ENZYME IMMUNOASSAY	Tosoh Medics, Inc.	2002-12-18	26	0
K023091	ST AIA-PACK TESTOSTERONE ASSAY	Tosoh Medics, Inc.	2002-12-17	91	1
K023894	ST AIA-PACK AFP ENZYME IMMUNOASSAY	Tosoh Medics, Inc.	2002-12-17	25	0
K023891	ST AIA-PACK CA 125 ENZYME IMMUNOASSAY	Tosoh Medics, Inc.	2002-12-06	14	0
K020489	G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE	Tosoh Medics, Inc.	2002-05-14	90	2
K012820	AIA-PACK CTNI 2ND-GEN ASSAY	Tosoh Medics, Inc.	2001-12-14	113	0
K011434	G7 AUTOMATED HPLC ANALYZER	Tosoh Medics, Inc.	2001-09-18	131	2
K010796	AIA-PACK BRCA, ST AIA PACK BRCA	Tosoh Medics, Inc.	2001-08-16	153	0
K992365	AIA-PACK FOLATE ASSAY	Tosoh Medics, Inc.	1999-08-10	26	1
K990431	AIA-PACK CA 125	Tosoh Medics, Inc.	1999-06-03	112	0
K991252	AIA-PACK FT3 ASSAY	Tosoh Medics, Inc.	1999-05-11	28	0
K984359	AIA-PACK TROPONIN I ASSAY	Tosoh Medics, Inc.	1998-12-23	16	0
K981521	AIA-PACK TPOAB ASSAY	Tosoh Medics, Inc.	1998-10-08	163	1
K981522	AIA-PACK TGAB ASSAY	Tosoh Medics, Inc.	1998-10-08	163	1
K981012	AIA-PACK MYOGLOBIN ASSAY	Tosoh Medics, Inc.	1998-05-28	71	0
K972697	AIA-PACK IGE II ASSAY	Tosoh Medics, Inc.	1997-10-03	77	0
K972265	A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER	Tosoh Medics, Inc.	1997-09-25	100	0
K972586	AIA-PACK TSH 3RD-GEN ASSAY	Tosoh Medics, Inc.	1997-08-29	49	0
K971103	AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM	Tosoh Medics, Inc.	1997-06-27	93	2
K964348	AIA-PACK B12 ASSAY	Tosoh Medics, Inc.	1997-01-13	74	0
K964349	AIA-PACK FOLATE ASSAY	Tosoh Medics, Inc.	1996-11-27	27	0
K963687	AIA-PACK FT3 ASSAY	Tosoh Medics, Inc.	1996-11-08	53	0
K951848	AIA-PACK CPR ASSAY	Tosoh Medics, Inc.	1996-02-13	298	0
K954591	AIA-PACK CORT ASSAY	Tosoh Medics, Inc.	1995-12-15	74	0
K936229	AIA-PACK TT3 ASSAY	Tosoh Medics, Inc.	1994-07-14	197	1
K932084	AIA-PACK E2 ASSAY	Tosoh Medics, Inc.	1993-11-09	193	0
K933269	AIA-PACK(R) PROG ASSAY	Tosoh Medics, Inc.	1993-10-22	108	0
K932178	AIA-PACK PA CALIBRATION VERIFICATION/LINEARITY TES	Tosoh Medics, Inc.	1993-09-21	139	0
K924859	AIA-PACK IGE CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1993-05-14	228	0
K924857	AIA-PACK CEA CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1993-03-18	171	0
K924860	AIA-PACK AFP CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1993-03-04	157	0
K924856	AIA-PACK PRL CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1993-01-11	105	0
K924852	ASIA-PACK TSH CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1993-01-11	105	0
K924862	AIA-PACK HCG CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1992-12-28	91	0
K924853	AIA-PACK BHCG CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1992-12-28	91	0
K924858	AIA-PACK FER CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1992-12-15	78	0
K924863	AIA-PACK FSH CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1992-11-16	49	0
K924854	AIA-PACK PAP CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1992-11-16	49	0
K924855	AIA-PACK T-U CALIBRATION VERIFICATION TEST SET	Tosoh Medics, Inc.	1992-11-16	49	0
K905757	AIA-PACK HGH	Tosoh Medics, Inc.	1991-01-25	29	0
K900440	AIA-PACK BMG	Tosoh Medics, Inc.	1990-02-26	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