Richards Medical Co., Inc.: FDA filings under this applicant name
FDA lists 71 510(k) clearances under the applicant name “Richards Medical Co., Inc.” (first 1983, latest 1990), across 33 product codes in 6 review panels. Median 510(k) review time under this name: 67 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Smith+Nephew, based on public ownership records.
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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | 7 | 7 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 7 | 7 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 7 | 7 |
| ETD | Tube, Tympanostomy | 4 | 4 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 | 4 |
| BXB | Exerciser, Powered | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| ETA | Replacement, Ossicular Prosthesis, Total | 2 | 2 |
| ETB | Prosthesis, Partial Ossicular Replacement | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
Plus 23 more product codes.
Review panels
- Orthopedic (39)
- Ear, Nose and Throat (20)
- General and Plastic Surgery (6)
- Physical Medicine (4)
- Dental (1)
- Ophthalmic (1)
Most recent Richards Medical Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K896106 | ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS | KWP | 1990-06-25 | 248 |
| K900628 | MODULAR HIP SYSTEM | LZO | 1990-05-09 | 90 |
| K896580 | UNI-POLAR HEAD | LZY | 1990-02-15 | 90 |
| K895241 | INTRAMEDULLARY HIP SCREW | KTT | 1990-01-04 | 136 |
| K884824 | TRICON-M TOTAL KNEE SYSTEM | MBV | 1989-11-21 | 368 |
| K896204 | ZIRCONIA CERAMIC HEAD ADD'L SIZES | LZO | 1989-11-20 | 25 |
| K895242 | PAPPAS TRI-FLANGE VENTILATION TUBE | ETD | 1989-11-17 | 88 |
| K893377 | RUSSELL-TAYLOR INTRAMEDULLARY KNEE FUSION NAILS | HSB | 1989-11-16 | 199 |
| K885069 | ZIRCONIA CERAMIC HEAD (YITRIA STABILIZED) | LZO | 1989-09-01 | 267 |
| K892366 | POROUS GENESIS STEMMED TIBIAL COMPONENT | JWH | 1989-07-19 | 104 |
61 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Richards Medical Co., Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Richards Manufacturer Co. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Richards Medical Co., Inc.?
FDA lists 71 510(k) clearances under the applicant name “Richards Medical Co., Inc.” (first 1983, latest 1990), across 33 product codes in 6 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 Richards Medical Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Richards Medical Co., Inc. is 67 days.
Which FDA product codes appear under Richards Medical Co., Inc.?
The most frequent FDA product codes under this applicant name are ESD (Hearing Aid, Air-Conduction, Prescription, 7); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 7); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 7).
Next steps
- See all 71 Richards Medical Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code ESD, Richards Medical Co., Inc.'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.