Smith & Nephew Perry: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Smith & Nephew Perry” (first 1991, latest 1993), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 157 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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 6 | 6 |
| LYY | Latex Patient Examination Glove | 4 | 4 |
Review panels
- General Hospital (10)
Most recent Smith & Nephew Perry 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932665 | ENCORE POWDER-FREE SURGICAL GLOVES MICROPTIC | KGO | 1993-12-22 | 203 |
| K932664 | ENCORE POWDER-FREE SURGICAL GLOVES ORTHOPAEDIA | KGO | 1993-12-22 | 203 |
| K931399 | PERRY ENHANCED PROTECTION LATEX SURGICAL GLOVE | LYY | 1993-11-18 | 244 |
| K923929 | PERRY POWDER-FREE GLOVES, STYLE 45G | KGO | 1993-02-10 | 189 |
| K922379 | STERILE LATEX EXAMINATION GLOVES | LYY | 1992-09-22 | 125 |
| K914445 | PERRY(R) NATURAL POWDER-FREE GLOVES, STYLE 45 | KGO | 1992-04-22 | 201 |
| K914942 | PERRY(R) CUT-RESISTANT GLOVES | LYY | 1992-01-31 | 88 |
| K913402 | PERRY(R) DERMAGUARD(R) PLUS GLOVES | KGO | 1991-10-02 | 64 |
| K911633 | PERRY(R) ENCORE CHEMOTHERAPY GLOVE | LYY | 1991-05-09 | 28 |
| K905537 | PERRY XTENDA CUFF SURGICAL GLOVES | KGO | 1991-01-11 | 31 |
Recalls
openFDA lists no recalls under a recalling firm named Smith & Nephew Perry.
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, Mpl Division (9 510(k)s)
- Smith & Nephew Inc., Endoscopy Division (8 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smith & Nephew Perry?
FDA lists 10 510(k) clearances under the applicant name “Smith & Nephew Perry” (first 1991, latest 1993), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Smith & Nephew Perry?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smith & Nephew Perry is 157 days.
Which FDA product codes appear under Smith & Nephew Perry?
The most frequent FDA product codes under this applicant name are KGO (Surgeon'S Gloves, 6); LYY (Latex Patient Examination Glove, 4).
Next steps
- See all 10 Smith & Nephew Perry clearances with predicates and recalls
- Run predicate analysis for product code KGO, Smith & Nephew Perry'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.