Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Keeler Limited — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
137 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152644 | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX | Keeler Limited | 2015-12-31 | 106 | 0 |
| K151394 | Keeler Slit Lamp | Keeler Limited | 2015-09-10 | 107 | 0 |
| K140451 | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEE | Keeler Limited | 2014-07-11 | 137 | 0 |
| K140450 | KEELER KAPTURE SOFTWARE | Keeler Limited | 2014-06-17 | 113 | 0 |
| K133234 | T-TYPE D-KAT, R-TYPE D-KAT | Keeler Limited | 2014-02-21 | 123 | 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