Richard'S Medical Equip., Inc.: FDA filings under this applicant name
FDA lists 48 510(k) clearances under the applicant name “Richard'S Medical Equip., Inc.” (first 1976, latest 1983), across 31 product codes in 5 review panels. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 7 | 7 |
| ETB | Prosthesis, Partial Ossicular Replacement | 5 | 5 |
| ETD | Tube, Tympanostomy | 4 | 4 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 3 | 3 |
| BXB | Exerciser, Powered | 2 | 2 |
| MBV | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| ETA | Replacement, Ossicular Prosthesis, Total | 1 | 1 |
| FZE | Prosthesis, Nose, Internal | 1 | 1 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 1 | 1 |
| GDW | Staple, Implantable | 1 | 1 |
Plus 21 more product codes.
Review panels
- Orthopedic (22)
- Ear, Nose and Throat (10)
- Physical Medicine (8)
- General and Plastic Surgery (6)
- Ophthalmic (1)
Most recent Richard'S Medical Equip., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K830793 | PATIENT GUIDED ELBOW & SHOULDER EXERC | BXB | 1983-06-16 | 94 |
| K823837 | RMC TOTAL KNEE SYSTEM | MBV | 1983-03-29 | 98 |
| K823726 | SPECTRON CONVERSION ENDOPROSTHESIS CUP | KWY | 1983-03-09 | 89 |
| K823724 | SPECTRON NECK REPLACEMENT PROSTHESIS | JDI | 1983-03-09 | 89 |
| K823723 | SPECTRON PROXIMAL FEMORAL PROSTHESIS | JDI | 1983-03-09 | 89 |
| K823727 | SPECTRON PRIMARY STEM FEMORAL PROSTHES | JDI | 1983-03-08 | 88 |
| K823722 | SPECTRON LONG, STRAIGHT FEMORAL PROSTHES | JDI | 1983-03-08 | 88 |
| K830153 | RICHARDS INTRA-ARTICULAR SHAVER BLADES | GEY | 1983-02-28 | 41 |
| K830154 | COLLES FRACTURE FRAME | JEC | 1983-02-02 | 15 |
| K823729 | SPECTRON METAL BACK ACETABULAR COMPONENT | JDI | 1983-01-21 | 42 |
38 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Richard'S Medical Equip., 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.
- Richard Wolf Medical Instruments Corp. (153 510(k)s)
- Richard Hamer Assoc., Inc. (8 510(k)s)
- Richard F. Kronner, M.D. (3 510(k)s)
- Richard James, Inc. (2 510(k)s)
- Richard D. Spradlin (1 510(k)s)
- Richard G. Deniro (1 510(k)s)
- Richard G. Lindsay (1 510(k)s)
- Richard J. Turner Assoc. (1 510(k)s)
- Richard R. Anthony, M.D. (1 510(k)s)
- Richard Scott Elliott (1 510(k)s)
- Richard Ting (1 510(k)s)
- Richard Van Haussen America, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Richard'S Medical Equip., Inc.?
FDA lists 48 510(k) clearances under the applicant name “Richard'S Medical Equip., Inc.” (first 1976, latest 1983), across 31 product codes in 5 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 Richard'S Medical Equip., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Richard'S Medical Equip., Inc. is 36 days.
Which FDA product codes appear under Richard'S Medical Equip., Inc.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 7); ETB (Prosthesis, Partial Ossicular Replacement, 5); ETD (Tube, Tympanostomy, 4).
Next steps
- See all 48 Richard'S Medical Equip., Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Richard'S Medical Equip., 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.