Acell, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Acell, Inc.” (first 2002, latest 2024), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 72 days. Since 2017 the median was 59 days, against 150 days for all cleared 510(k)s in the same product codes. 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 | 2 | 246 |
| 2016 | 2 | 57 |
| 2017 | 2 | 73 |
| 2018 | 1 | 49 |
| 2019 | 3 | 147 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 170 |
| 2024 | 2 | 28 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Acell, Inc. took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | 13 | 13 |
| FTM | Mesh, Surgical | 6 | 6 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | 1 | 1 |
Review panels
Most recent Acell, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | KGN | 2024-07-11 | 27 |
| K241706 | MicroMatrix® UBM Particulate | KGN | 2024-07-11 | 28 |
| K230980 | MicroMatrix® Flex | KGN | 2023-09-22 | 170 |
| K191734 | MatriStem UBM Pericardial Patch | PSQ | 2019-11-22 | 147 |
| K192725 | Cytal Wound Matrix 3-Layer | KGN | 2019-10-25 | 28 |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | FTM | 2019-02-07 | 170 |
| K180776 | Cytal Wound Particulate | KGN | 2018-05-11 | 49 |
| K172399 | MicroMatrix | KGN | 2017-10-06 | 59 |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | FTM | 2017-06-08 | 87 |
| K162554 | Gentrix Surgical Matrix | FTM | 2016-10-21 | 38 |
10 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2019-02-14.
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 Acell, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Acell, Inc.” (first 2002, latest 2024), across 3 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 Acell, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acell, Inc. is 72 days. Since 2017: 59 days, versus 150 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Acell, Inc.?
The most frequent FDA product codes under this applicant name are KGN (Wound Dressing With Animal-Derived Material(S), 13); FTM (Mesh, Surgical, 6); PSQ (Intracardiac Patch Or Pledget, Biologically Derived, 1).
Next steps
- See all 20 Acell, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGN, Acell, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.