Smith: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Smith” (first 1997, latest 1998), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 50 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 |
|---|---|---|---|
| EWO | Audiometer | 1 | 1 |
| FMQ | Restraint, Protective | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| LDQ | 1 | 1 | |
| LGZ | Warmer, Thermal, Infusion Fluid | 1 | 1 |
Review panels
Most recent Smith 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K973747 | CONTROLLED TEMPERATURE CABINET SYSTEM | LDQ | 1998-05-07 | 218 |
| K973748 | TEMPO AND TEMP H20 | LGZ | 1998-03-10 | 160 |
| K972123 | PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905 | FMQ | 1997-07-25 | 50 |
| K971092 | QA-ES | GEI | 1997-04-23 | 28 |
| K970555 | IL0292 DP ECHOPORT | EWO | 1997-03-17 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Smith.
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. (556 510(k)s)
- Smith & Nephew Richards, Inc. (87 510(k)s)
- Smith & Nephew United, Inc. (34 510(k)s)
- Smith & Nephew Medical Limited (30 510(k)s)
- Smith & Nephew Dyonics, Inc. (22 510(k)s)
- Smith & Nephew Endoscopy, Inc. (18 510(k)s)
- Smith and Nephew Donjoy, Inc. (15 510(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?
FDA lists 5 510(k) clearances under the applicant name “Smith” (first 1997, latest 1998), across 5 product codes in 3 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?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith is 50 days.
Which FDA product codes appear under Smith?
The most frequent FDA product codes under this applicant name are EWO (Audiometer, 1); FMQ (Restraint, Protective, 1); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 1).
Next steps
- See all 5 Smith clearances with predicates and recalls
- Run predicate analysis for product code EWO, Smith'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.