American Threshold Industries, Inc.: FDA clearances and approvals
American Threshold Industries, Inc. has 20 FDA 510(k) clearances (first 1980, latest 1997), across 13 product codes in 4 review panels. Median 510(k) review time: 104 days.
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 |
|---|---|---|---|
| FYC | Gown, Isolation, Surgical | 4 | 4 |
| FRG | Wrap, Sterilization | 2 | 2 |
| FYF | Cap, Surgical | 2 | 2 |
| KKX | Drape, Surgical, Antimicrobial | 2 | 2 |
| KME | Bedding, Disposable, Medical | 2 | 2 |
| FMW | Cover, Mattress (Medical Purposes) | 1 | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| HAX | Tong, Skull For Traction | 1 | 1 |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | 1 | 1 |
Plus 3 more product codes.
Review panels
- General Hospital (14)
- General and Plastic Surgery (3)
- Neurology (1)
- Ophthalmic (1)
Most recent American Threshold Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971483 | SECURE-WRAP (TM) STERILIZATION WRAP | FRG | 1997-06-24 | 62 |
| K953879 | SURGEON'S CAP | FYF | 1996-01-05 | 142 |
| K953878 | BOUFFANT CAP | FYF | 1996-01-05 | 142 |
| K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN | FYC | 1995-09-25 | 143 |
| K952114 | KOOL GARD SINGLES GOWN | FYC | 1995-09-25 | 143 |
| K952116 | COVER GOWN | FYC | 1995-09-05 | 123 |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | HOY | 1993-11-12 | 84 |
| K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | HAX | 1992-08-17 | 251 |
| K915740 | DISPOSABLE O.R. TOWEL, STERILE | KKX | 1992-06-22 | 182 |
| K912110 | DISPOSABLE O.R. TOWEL | KKX | 1991-07-25 | 73 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Threshold Industries, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does American Threshold Industries, Inc. have?
American Threshold Industries, Inc. has 20 FDA 510(k) clearances (first 1980, latest 1997), across 13 product codes in 4 review panels.
How long does FDA take to clear American Threshold Industries, Inc.'s 510(k)s?
The median time from FDA receipt to decision across American Threshold Industries, Inc.'s cleared 510(k)s is 104 days.
What devices does American Threshold Industries, Inc. make?
Its most frequent FDA product codes are FYC (Gown, Isolation, Surgical, 4); FRG (Wrap, Sterilization, 2); FYF (Cap, Surgical, 2).
Has American Threshold Industries, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching American Threshold Industries, Inc. Related entities may recall under other names.
Next steps
- See all 20 American Threshold Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FYC, American Threshold Industries, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.