R. A. Fischer Co. Corp.: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “R. A. Fischer Co. Corp.” (first 1976, latest 1997), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 49 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| KCW | Epilator, High Frequency, Needle-Type | 8 | 8 |
| EGJ | Device, Iontophoresis, Other Uses | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| FTC | Light, Ultraviolet, Dermatological | 1 | 1 |
Review panels
Most recent R. A. Fischer Co. Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964208 | MD-1A GALVANIC UNIT | EGJ | 1997-04-30 | 208 |
| K954031 | COMPU-BLEND EPILATOR | KCW | 1996-01-05 | 130 |
| K895365 | MD-2 IONTOPHORESIS UNIT | EGJ | 1990-06-26 | 302 |
| K893389 | MODEL SE-5 EPILATOR | KCW | 1989-06-05 | 35 |
| K884079 | MODEL CBX EPILATOR | KCW | 1988-10-04 | 7 |
| K871372 | CB-7 ELECTRONIC EPILATOR | KCW | 1987-04-28 | 21 |
| K852534 | ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9 | FTC | 1985-11-08 | 147 |
| K843063 | ELECTRONIC EPILATOR TS-1 | KCW | 1984-09-26 | 51 |
| K823674 | HIGH FREQUENCY EPILATOR CB-2 | KCW | 1983-01-14 | 38 |
| K801351 | EPILATOR, MODEL CP-16 | KCW | 1980-07-28 | 49 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named R. A. Fischer Co. Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under R. A. Fischer Co. Corp.?
FDA lists 13 510(k) clearances under the applicant name “R. A. Fischer Co. Corp.” (first 1976, latest 1997), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by R. A. Fischer Co. Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name R. A. Fischer Co. Corp. is 49 days.
Which FDA product codes appear under R. A. Fischer Co. Corp.?
The most frequent FDA product codes under this applicant name are KCW (Epilator, High Frequency, Needle-Type, 8); EGJ (Device, Iontophoresis, Other Uses, 2); IPF (Stimulator, Muscle, Powered, 2).
Next steps
- See all 13 R. A. Fischer Co. Corp. clearances with predicates and recalls
- Run predicate analysis for product code KCW, R. A. Fischer Co. Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.