Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Standard Textile Co., Inc. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
324 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241214 | ProPel SG3™ Surgical Gown | Standard Textile Co., Inc. | 2024-09-10 | 133 | 0 |
| K172207 | Standard Supreme Sterilization Wrapper | Standard Textile Co., Inc. | 2017-08-25 | 35 | 0 |
| K162162 | Barrier Supreme Sterilization Wrapper | Standard Textile Co., Inc. | 2016-11-04 | 94 | 0 |
| K060181 | COMPE1 1 -PLY SURGICAL GOWNS | Standard Textile Co., Inc. | 2006-03-07 | 43 | 0 |
| K041653 | COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS | Standard Textile Co., Inc. | 2005-07-01 | 379 | 0 |
| K041540 | COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS | Standard Textile Co., Inc. | 2005-05-05 | 331 | 0 |
| K041539 | COMPEL SURGICAL GOWNS | Standard Textile Co., Inc. | 2005-04-28 | 324 | 0 |
| K041541 | COMPEL MLR SURGICAL GOWNS | Standard Textile Co., Inc. | 2005-03-16 | 281 | 0 |
| K012268 | TRIMAX | Standard Textile Co., Inc. | 2001-12-03 | 137 | 0 |
| K012807 | MODIFICATION TO: COMPEL SURGICAL DRAPES | Standard Textile Co., Inc. | 2001-10-11 | 50 | 0 |
| K010799 | COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) | Standard Textile Co., Inc. | 2001-06-07 | 83 | 0 |
| K980183 | PROMAX SURGICAL DRAPES AND COVERS | Standard Textile Co., Inc. | 1998-02-26 | 37 | 0 |
| K945371 | COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS | Standard Textile Co., Inc. | 1995-04-27 | 176 | 0 |
| K950504 | PERVAL SURGICAL GOWN (MARKETING NAME) | Standard Textile Co., Inc. | 1995-04-25 | 78 | 0 |
| K944863 | COMPEL SURGICALDRAPES | Standard Textile Co., Inc. | 1995-02-28 | 148 | 0 |
| K940758 | COMPEL SURGICAL GOWNS | Standard Textile Co., Inc. | 1994-04-22 | 63 | 0 |
| K923408 | WRAPPEL T | Standard Textile Co., Inc. | 1993-04-08 | 272 | 0 |
| K922753 | COMPEL XTR | Standard Textile Co., Inc. | 1993-03-09 | 274 | 0 |
| K923811 | COMPEL SURGICAL DRAPES | Standard Textile Co., Inc. | 1993-02-23 | 209 | 0 |
| K921889 | COMPEL O AND R | Standard Textile Co., Inc. | 1993-02-18 | 302 | 0 |
| K914839 | COMPEL E | Standard Textile Co., Inc. | 1992-04-02 | 160 | 0 |
| K882684 | REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS. | Standard Textile Co., Inc. | 1988-08-03 | 34 | 0 |
| K860447 | STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400 | Standard Textile Co., Inc. | 1986-02-19 | 15 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda