F. & F. Koenigkramer: FDA clearances and approvals
F. & F. Koenigkramer has 9 FDA 510(k) clearances (first 1977, latest 1986), across 7 product codes in 4 review panels. Median 510(k) review time: 38 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 |
|---|---|---|---|
| HME | Chair, Ophthalmic, Ac-Powered | 3 | 3 |
| ETF | Unit, Examining/Treatment, Ent | 1 | 1 |
| FPO | Stretcher, Wheeled | 1 | 1 |
| HHF | Remover, Intrauterine Device, Contraceptive, Hook-Type | 1 | 1 |
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | 1 | 1 |
| HQF | Laser, Ophthalmic | 1 | 1 |
| LGX | Table, Examination, Medical, Powered | 1 | 1 |
Review panels
Most recent F. & F. Koenigkramer 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K860519 | RELIANCE MODEL 200 PODIATRY CHAIR | LGX | 1986-02-19 | 8 |
| K853151 | RELIANCE 5000 | HME | 1985-09-05 | 38 |
| K853150 | RELIANCE 6100 | HME | 1985-09-05 | 38 |
| K853149 | RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 | HME | 1985-09-05 | 38 |
| K843046 | RELIANCE TREATMENT CABINET | ETF | 1984-09-27 | 56 |
| K834060 | RELIANCE OPHTHALMIC SLIT LAMP R-083 | HQF | 1984-02-04 | 71 |
| K831568 | RELIANCE TEMPO OPHTH. INSTR STAND | HHF | 1983-06-30 | 45 |
| K812544 | RELIANCE OPHTHALMIC INSTRUMENT CONTROL | HMF | 1981-09-21 | 17 |
| K761147 | RELIANCE MOD-U-LINE M-700 | FPO | 1977-01-28 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named F. & F. Koenigkramer.
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 F. & F. Koenigkramer have?
F. & F. Koenigkramer has 9 FDA 510(k) clearances (first 1977, latest 1986), across 7 product codes in 4 review panels.
How long does FDA take to clear F. & F. Koenigkramer's 510(k)s?
The median time from FDA receipt to decision across F. & F. Koenigkramer's cleared 510(k)s is 38 days.
What devices does F. & F. Koenigkramer make?
Its most frequent FDA product codes are HME (Chair, Ophthalmic, Ac-Powered, 3); ETF (Unit, Examining/Treatment, Ent, 1); FPO (Stretcher, Wheeled, 1).
Has F. & F. Koenigkramer had device recalls?
openFDA lists no recalls under a recalling firm name matching F. & F. Koenigkramer. Related entities may recall under other names.
Next steps
- See all 9 F. & F. Koenigkramer clearances with predicates and recalls
- Run predicate analysis for product code HME, F. & F. Koenigkramer'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.