Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
R. A. Fischer Co. Corp. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
208 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964208 | MD-1A GALVANIC UNIT | R. A. Fischer Co. Corp. | 1997-04-30 | 208 | 0 |
| K954031 | COMPU-BLEND EPILATOR | R. A. Fischer Co. Corp. | 1996-01-05 | 130 | 0 |
| K895365 | MD-2 IONTOPHORESIS UNIT | R. A. Fischer Co. Corp. | 1990-06-26 | 302 | 0 |
| K893389 | MODEL SE-5 EPILATOR | R. A. Fischer Co. Corp. | 1989-06-05 | 35 | 0 |
| K884079 | MODEL CBX EPILATOR | R. A. Fischer Co. Corp. | 1988-10-04 | 7 | 0 |
| K871372 | CB-7 ELECTRONIC EPILATOR | R. A. Fischer Co. Corp. | 1987-04-28 | 21 | 0 |
| K852534 | ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9 | R. A. Fischer Co. Corp. | 1985-11-08 | 147 | 0 |
| K843063 | ELECTRONIC EPILATOR TS-1 | R. A. Fischer Co. Corp. | 1984-09-26 | 51 | 0 |
| K823674 | HIGH FREQUENCY EPILATOR CB-2 | R. A. Fischer Co. Corp. | 1983-01-14 | 38 | 0 |
| K801351 | EPILATOR, MODEL CP-16 | R. A. Fischer Co. Corp. | 1980-07-28 | 49 | 0 |
| K780076 | EPILATOR, ELECTRONIC MODEL SE-2 | R. A. Fischer Co. Corp. | 1978-01-24 | 8 | 0 |
| K760547 | STIMULATOR, ELECTRICAL MUSCLE (#MD-4) | R. A. Fischer Co. Corp. | 1977-02-17 | 171 | 0 |
| K760503 | STIMULATOR, ELECTRICAL MUSCLE (#MD-8) | R. A. Fischer Co. Corp. | 1976-09-27 | 35 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda