Keeler Instruments, Inc.: FDA clearances and approvals
Keeler Instruments, Inc. has 60 FDA 510(k) clearances (first 1981, latest 2019), across 30 product codes in 5 review panels. Median 510(k) review time: 58 days. openFDA lists 1 product recall by a recalling firm named Keeler Instruments, Inc.
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 | 1 | 283 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Keeler Instruments, Inc.'s cleared 510(k)s took a median 283 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | 6 | 6 |
| HKX | Tonometer, Ac-Powered | 5 | 5 |
| GZX | Instrument, Microsurgical | 4 | 4 |
| HNN | Knife, Ophthalmic | 4 | 4 |
| HRM | Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | 4 | 4 |
| HLJ | Ophthalmoscope, Battery-Powered | 3 | 3 |
| HQF | Laser, Ophthalmic | 3 | 3 |
| HRN | Unit, Cryophthalmic, Ac-Powered | 3 | 3 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | 2 | 2 |
| HMP | Pad, Eye | 2 | 2 |
Plus 20 more product codes.
Review panels
- Ophthalmic (44)
- General and Plastic Surgery (8)
- Neurology (4)
- Cardiovascular (2)
- Orthopedic (1)
Most recent Keeler Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K181143 | Keeler TonoCare Tonometer | HKX | 2019-02-08 | 283 |
| K112093 | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER | HRN | 2011-12-08 | 139 |
| K093298 | PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 | HKX | 2010-12-10 | 415 |
| K100500 | PSL CLASSIC SLIT LAMP | HJO | 2010-03-09 | 15 |
| K062412 | CRYOMATIC | HRN | 2006-11-06 | 81 |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | HLI | 2006-05-23 | 57 |
| K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | HLJ | 2003-11-26 | 142 |
| K992954 | KEELER CRYO MASTER & PROBES | HRN | 1999-12-21 | 111 |
| K990257 | KEELER PULSAIR 3000 NON CONTACT TONOMETER | HKX | 1999-03-25 | 57 |
| K973064 | KEELER TEARSCOPE-PLUS | HJO | 1998-04-07 | 232 |
50 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2008-01-08.
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 Instruments, Inc. have?
Keeler Instruments, Inc. has 60 FDA 510(k) clearances (first 1981, latest 2019), across 30 product codes in 5 review panels.
How long does FDA take to clear Keeler Instruments, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Keeler Instruments, Inc.'s cleared 510(k)s is 58 days.
What devices does Keeler Instruments, Inc. make?
Its most frequent FDA product codes are HLI (Ophthalmoscope, Ac-Powered, 6); HKX (Tonometer, Ac-Powered, 5); GZX (Instrument, Microsurgical, 4).
Has Keeler Instruments, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Keeler Instruments, Inc; the most recent began 2008-01-08. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 60 Keeler Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HLI, Keeler 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.