Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kowa Co. , Ltd. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
107 daysmedian FDA review time
272 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133755 | KOWA SL-17 | Kowa Co. , Ltd. | 2014-03-11 | 92 | 0 |
| K112330 | KOWA VX-20 | Kowa Co. , Ltd. | 2012-02-16 | 188 | 0 |
| K101628 | KOWA NONMYD WX | Kowa Co. , Ltd. | 2011-01-26 | 230 | 0 |
| K091098 | KOWAGENESIS-DF | Kowa Co. , Ltd. | 2009-08-07 | 113 | 0 |
| K091039 | KOWA, FM-600, MODEL LSS50 | Kowa Co. , Ltd. | 2009-08-07 | 116 | 0 |
| K091683 | KOWA VX-10 A | Kowa Co. , Ltd. | 2009-07-02 | 22 | 0 |
| K083387 | MODIFICATION TO KOWA NONMYD ALPHA-DIII | Kowa Co. , Ltd. | 2009-01-16 | 60 | 0 |
| K082767 | KOWA NONMYD ALPHA-DIII | Kowa Co. , Ltd. | 2008-10-21 | 29 | 0 |
| K080681 | KOWA GENESIS-D | Kowa Co. , Ltd. | 2008-04-04 | 25 | 0 |
| K063640 | KOWA SL-15 | Kowa Co. , Ltd. | 2006-12-18 | 11 | 0 |
| K062021 | KOWA VX-10I | Kowa Co. , Ltd. | 2006-11-01 | 107 | 0 |
| K062356 | KOWA NONMYD ALPHA-D | Kowa Co. , Ltd. | 2006-09-27 | 44 | 0 |
| K053444 | KOWA KT-800 | Kowa Co. , Ltd. | 2006-06-09 | 182 | 0 |
| K053026 | KOWA NONMYD 7, KOWA NONMYD A-D | Kowa Co. , Ltd. | 2005-11-10 | 14 | 0 |
| K050271 | KOWA GENESIS-D HAND-HELD RETINAL CAMERA | Kowa Co. , Ltd. | 2005-11-03 | 272 | 0 |
| K043213 | KOWA VX-10 | Kowa Co. , Ltd. | 2005-10-06 | 321 | 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