Keeler Limited: FDA clearances and approvals
Keeler Limited has 5 FDA 510(k) clearances (first 2014, latest 2015), across 3 product codes in 1 review panel. Median 510(k) review time: 113 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 3 | 123 |
| 2015 | 2 | 106 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | 2 |
| HKY | Tonometer, Manual | 2 | 2 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (5)
Most recent Keeler Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152644 | KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 | HKY | 2015-12-31 | 106 |
| K151394 | Keeler Slit Lamp | HJO | 2015-09-10 | 107 |
| K140451 | KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION) | HJO | 2014-07-11 | 137 |
| K140450 | KEELER KAPTURE SOFTWARE | HKI | 2014-06-17 | 113 |
| K133234 | T-TYPE D-KAT, R-TYPE D-KAT | HKY | 2014-02-21 | 123 |
Recalls
openFDA lists no recalls under a recalling firm named Keeler Limited.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Keeler Limited have?
Keeler Limited has 5 FDA 510(k) clearances (first 2014, latest 2015), across 3 product codes in 1 review panel.
How long does FDA take to clear Keeler Limited's 510(k)s?
The median time from FDA receipt to decision across Keeler Limited's cleared 510(k)s is 113 days.
What devices does Keeler Limited make?
Its most frequent FDA product codes are HJO (Biomicroscope, Slit-Lamp, Ac-Powered, 2); HKY (Tonometer, Manual, 2); HKI (Camera, Ophthalmic, Ac-Powered, 1).
Has Keeler Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Keeler Limited. Related entities may recall under other names.
Next steps
- See all 5 Keeler Limited clearances with predicates and recalls
- Run predicate analysis for product code HJO, Keeler Limited's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.