Acutek Adhesive Specialties, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Acutek Adhesive Specialties, Inc.” (first 1994, latest 1998), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 186 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 |
|---|---|---|---|
| MGP | Dressing, Wound And Burn, Occlusive | 4 | 4 |
| LWF | Dilator, Nasal | 2 | 2 |
Review panels
Most recent Acutek Adhesive Specialties, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974891 | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 | MGP | 1998-10-21 | 295 |
| K974892 | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 | MGP | 1998-10-13 | 287 |
| K974890 | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 | MGP | 1998-10-13 | 287 |
| K962698 | ACUTEK'S CLEARPASAGE | LWF | 1996-09-09 | 84 |
| K951644 | ACUTEK'S CLEARPASSAGE | LWF | 1995-07-03 | 84 |
| K943111 | TRANSPARENT DRESSING | MGP | 1994-09-12 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Acutek Adhesive 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.
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.
- Acutek (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acutek Adhesive Specialties, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Acutek Adhesive Specialties, Inc.” (first 1994, latest 1998), across 2 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 Acutek Adhesive Specialties, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acutek Adhesive Specialties, Inc. is 186 days.
Which FDA product codes appear under Acutek Adhesive Specialties, Inc.?
The most frequent FDA product codes under this applicant name are MGP (Dressing, Wound And Burn, Occlusive, 4); LWF (Dilator, Nasal, 2).
Next steps
- See all 6 Acutek Adhesive Specialties, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MGP, Acutek Adhesive 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.