Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kowa Optimed, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
330 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013805 | KOWA AUTOMATED TONOMETER KT-500 | Kowa Optimed, Inc. | 2002-10-11 | 330 | 0 |
| K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 | Kowa Optimed, Inc. | 1996-06-17 | 90 | 0 |
| K960924 | KOWA HAND-HELD APPLANATION TONOMETER HA-1 | Kowa Optimed, Inc. | 1996-06-04 | 90 | 0 |
| K955442 | KOWA SC-1200 PHOTO SLIT LAMP SYSTEM | Kowa Optimed, Inc. | 1996-01-03 | 36 | 0 |
| K954781 | KOWA GENESIS HAND-HELD FUNDUS CAMERA | Kowa Optimed, Inc. | 1995-12-01 | 45 | 0 |
| K954780 | KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-5 | Kowa Optimed, Inc. | 1995-12-01 | 45 | 0 |
| K954782 | KOWA PORTABLE SLIT LAMP SL-14 & SL-14B | Kowa Optimed, Inc. | 1995-11-24 | 38 | 0 |
| K913852 | LASER FLARE METER | Kowa Optimed, Inc. | 1992-02-07 | 164 | 0 |
| K880920 | LASER FLARE CELL METER FC-1000 | Kowa Optimed, Inc. | 1988-09-27 | 207 | 0 |
| K881219 | AUTOMATIC PERIMETER, AP-340 | Kowa Optimed, Inc. | 1988-05-03 | 42 | 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