Standard Textile Co., Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Standard Textile Co., Inc.” (first 1986, latest 2024), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 137 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 | 1 | 94 |
| 2017 | 1 | 35 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 133 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Standard Textile Co., Inc. took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 184 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FYA | Gown, Surgical | 14 | 14 |
| KKX | Drape, Surgical, Antimicrobial | 5 | 5 |
| FRG | Wrap, Sterilization | 3 | 3 |
| LRO | General Surgery Tray | 1 | 1 |
Review panels
Most recent Standard Textile Co., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241214 | ProPel SG3 Surgical Gown | FYA | 2024-09-10 | 133 |
| K172207 | Standard Supreme Sterilization Wrapper | FRG | 2017-08-25 | 35 |
| K162162 | Barrier Supreme Sterilization Wrapper | FRG | 2016-11-04 | 94 |
| K060181 | COMPE1 1 -PLY SURGICAL GOWNS | FYA | 2006-03-07 | 43 |
| K041653 | COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS | FYA | 2005-07-01 | 379 |
| K041540 | COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS | FYA | 2005-05-05 | 331 |
| K041539 | COMPEL SURGICAL GOWNS | FYA | 2005-04-28 | 324 |
| K041541 | COMPEL MLR SURGICAL GOWNS | FYA | 2005-03-16 | 281 |
| K012268 | TRIMAX | FYA | 2001-12-03 | 137 |
| K012807 | MODIFICATION TO: COMPEL SURGICAL DRAPES | KKX | 2001-10-11 | 50 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Standard Textile 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.
- Standard Bariatrics (12 510(k)s)
- Standard Imaging, Inc. (10 510(k)s)
- Standard Diagnostics, Inc. (3 510(k)s)
- Standard Welders Supply Co. (3 510(k)s)
- Standard Engineering (1 510(k)s)
- Standard Scientific, Inc. (1 510(k)s)
- Standard Surgical (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Standard Textile Co., Inc.?
FDA lists 23 510(k) clearances under the applicant name “Standard Textile Co., Inc.” (first 1986, latest 2024), across 4 product codes in 2 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 Standard Textile Co., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Standard Textile Co., Inc. is 137 days.
Which FDA product codes appear under Standard Textile Co., Inc.?
The most frequent FDA product codes under this applicant name are FYA (Gown, Surgical, 14); KKX (Drape, Surgical, Antimicrobial, 5); FRG (Wrap, Sterilization, 3).
Next steps
- See all 23 Standard Textile Co., Inc. clearances with predicates and recalls
- Run predicate analysis for product code FYA, Standard Textile 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.