Smith and Nephew Donjoy, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Smith and Nephew Donjoy, Inc.” (first 1991, latest 1997), across 8 product codes in 5 review panels. Median 510(k) review time under this name: 123 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 4 | 4 |
| FMQ | Restraint, Protective | 3 | 3 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| HCC | Device, Biofeedback | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
| IPF | Stimulator, Muscle, Powered | 1 | 1 |
| KGX | Tape And Bandage, Adhesive | 1 | 1 |
Review panels
- Orthopedic (5)
- Neurology (4)
- General Hospital (3)
- Physical Medicine (2)
- General and Plastic Surgery (1)
Most recent Smith and Nephew Donjoy, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970051 | MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE | HCC | 1997-07-10 | 184 |
| K963492 | PROTECTIVE RESTRAINT | FMQ | 1996-11-12 | 70 |
| K963490 | PROTECTIVE RESTRAINT - BELTS | FMQ | 1996-11-12 | 70 |
| K963489 | WHEEL CHAIR ACCESSORY | FMQ | 1996-11-12 | 70 |
| K962462 | MUSCLEMAX PLUS ELECTRICAL MUSCLE STIMULATOR | IPF | 1996-09-23 | 90 |
| K955057 | MODEL 1100 COLD THERAPY DEVICE | ILO | 1996-03-08 | 123 |
| K951350 | MUSCLESENSE ELECTROMYOGRAPHY DEVICE | HCC | 1995-06-23 | 91 |
| K945687 | ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW | HWC | 1995-06-22 | 213 |
| K946313 | TIBIAL ROUTERS, FEMORAL ROUTERS AND TUBE GRAFT SIZER | HRX | 1995-03-17 | 79 |
| K945236 | AIMS CANNULATED ACL SCREW (7MM DIAMETER) | HWC | 1995-02-03 | 99 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Smith and Nephew Donjoy, 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.
- Smith & Nephew, Inc. (547 510(k)s)
- Smith & Nephew Richards, Inc. (87 510(k)s)
- Smith & Nephew United, Inc. (34 510(k)s)
- Smith & Nephew Dyonics, Inc. (22 510(k)s)
- Smith & Nephew Medical Limited (20 510(k)s)
- Smith & Nephew Endoscopy, Inc. (18 510(k)s)
- Smith & Nephew Medical, Ltd. (12 510(k)s)
- Smith River Biologicals (12 510(k)s)
- Smith & Nephew Inc., Endoscopy Div. (10 510(k)s)
- Smith & Nephew, Inc., Orthopaedic Div. (10 510(k)s)
- Smith & Nephew Perry (10 510(k)s)
- Smith & Nephew, Mpl Division (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smith and Nephew Donjoy, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Smith and Nephew Donjoy, Inc.” (first 1991, latest 1997), across 8 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 Smith and Nephew Donjoy, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith and Nephew Donjoy, Inc. is 123 days.
Which FDA product codes appear under Smith and Nephew Donjoy, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 4); FMQ (Restraint, Protective, 3); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2).
Next steps
- See all 15 Smith and Nephew Donjoy, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Smith and Nephew Donjoy, 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.