Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Richards Manufacturer Co. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831999 | FEMORAL CANAL SUCTION TAMPON | Richards Manufacturer Co. | 1983-09-29 | 100 | 0 |
| K831884 | SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL | Richards Manufacturer Co. | 1983-09-20 | 99 | 0 |
| K832000 | THIGH HOLDER | Richards Manufacturer Co. | 1983-07-12 | 21 | 0 |
| K831656 | ARTHROSCOPY KNIVES/PROBES/BENDING TOOL | Richards Manufacturer Co. | 1983-06-30 | 38 | 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