Atlas FDA

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

Tosoh Corp. — Predicate Candidate Screening

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

45 daysmedian FDA review time
87 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023239AIA-PACK CA 19-9Tosoh Corp.2002-12-23870
K023240ST AIA-PACK CA 19-9Tosoh Corp.2002-12-23870
K923021AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Corp.1992-07-21280
K913663AIA-PACK T-UTosoh Corp.1991-09-30450
K913298AIA-PACK CK-MBTosoh Corp.1991-09-27640
K913493AIA-PACK FT4Tosoh Corp.1991-09-10350
K903628AIA-PACK IRITosoh Corp.1990-09-07280
K901965MPR-4A - MICRO-PLATE READERTosoh Corp.1990-05-10100
K901674AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEMTosoh Corp.1990-05-02220
K897001TOSOH AIA-PACK T3Tosoh Corp.1990-03-09810
K896982AIA-PACK T4Tosoh Corp.1990-03-09800

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