Thantex Specialties, Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Thantex Specialties, Inc.” (first 1994, latest 1997), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 181 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 |
|---|---|---|---|
| GDY | Gauze/Sponge, Internal, X-Ray Detectable | 7 | 7 |
| EFQ | Gauze/Sponge, Internal | 3 | 3 |
| KKX | Drape, Surgical, Antimicrobial | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| FYA | Gown, Surgical | 2 | 2 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| FYC | Gown, Isolation, Surgical | 1 | 1 |
| KME | Bedding, Disposable, Medical | 1 | 1 |
| LYU | Accessory, Surgical Apparel | 1 | 1 |
Review panels
Most recent Thantex Specialties, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970547 | ISOLYSER SDS SHARPS CONTAINER | FMI | 1997-07-18 | 156 |
| K961083 | OREX SURGEON'S VEST | FYA | 1996-08-23 | 157 |
| K942200 | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS | LYU | 1995-08-07 | 459 |
| K943626 | ISOLYSER SHARPS MANAGEMENT SYSTEM SMS | FMI | 1995-06-16 | 325 |
| K945755 | OREX(R) O.R EQUIPMENT DRAPES | KKX | 1995-05-25 | 183 |
| K945223 | OREX ISOLATION GOWN | FYC | 1995-04-25 | 181 |
| K944859 | OREX SURGICAL DRAPES | KKX | 1995-02-28 | 148 |
| K944827 | OREX SURGEON'S GOWN | FYA | 1995-02-28 | 152 |
| K943034 | OREX SHOE COVERS | FXP | 1995-01-02 | 189 |
| K942228 | OREX O.R. TOWEL | KKX | 1994-12-20 | 228 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Thantex Specialties, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Thantex Specialties, Inc.?
FDA lists 21 510(k) clearances under the applicant name “Thantex Specialties, Inc.” (first 1994, latest 1997), across 9 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 Thantex Specialties, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thantex Specialties, Inc. is 181 days.
Which FDA product codes appear under Thantex Specialties, Inc.?
The most frequent FDA product codes under this applicant name are GDY (Gauze/Sponge, Internal, X-Ray Detectable, 7); EFQ (Gauze/Sponge, Internal, 3); KKX (Drape, Surgical, Antimicrobial, 3).
Next steps
- See all 21 Thantex Specialties, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GDY, Thantex Specialties, 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.