Keller Instruments, Inc.: FDA clearances and approvals
Keller Instruments, Inc. has 5 FDA 510(k) clearances (first 1983, latest 1985), across 4 product codes in 2 review panels. Median 510(k) review time: 41 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 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 |
|---|---|---|---|
| HQA | Unit, Cryotherapy, Ophthalmic | 2 | 2 |
| GEN | Forceps, General & Plastic Surgery | 1 | 1 |
| HLJ | Ophthalmoscope, Battery-Powered | 1 | 1 |
| HLT | Preamplifier, Ac-Powered, Ophthalmic | 1 | 1 |
Review panels
Most recent Keller Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854541 | TIP OFF FORCEPS | GEN | 1985-12-17 | 34 |
| K841294 | ACU220 CRYO UNIT | HQA | 1984-08-15 | 139 |
| K841293 | PANORAMIC LOUPES - VARIOUS | HLT | 1984-05-09 | 41 |
| K841292 | SPECTACLE INDIRECT OPHTHALMOSCOPE | HLJ | 1984-05-09 | 41 |
| K823835 | SPEMBLY 140 CRYOSYSTEM PROBES & TIPS | HQA | 1983-01-17 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Keller Instruments, Inc..
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 Keller Instruments, Inc. have?
Keller Instruments, Inc. has 5 FDA 510(k) clearances (first 1983, latest 1985), across 4 product codes in 2 review panels.
How long does FDA take to clear Keller Instruments, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Keller Instruments, Inc.'s cleared 510(k)s is 41 days.
What devices does Keller Instruments, Inc. make?
Its most frequent FDA product codes are HQA (Unit, Cryotherapy, Ophthalmic, 2); GEN (Forceps, General & Plastic Surgery, 1); HLJ (Ophthalmoscope, Battery-Powered, 1).
Has Keller Instruments, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Keller Instruments, Inc. Related entities may recall under other names.
Next steps
- See all 5 Keller Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQA, Keller Instruments, Inc.'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.