Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acell, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
216 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | Acell, Inc. | 2024-07-11 | 27 | 0 |
| K241706 | MicroMatrix® UBM Particulate | Acell, Inc. | 2024-07-11 | 28 | 0 |
| K230980 | MicroMatrix® Flex | Acell, Inc. | 2023-09-22 | 170 | 0 |
| K191734 | MatriStem UBM Pericardial Patch | Acell, Inc. | 2019-11-22 | 147 | 0 |
| K192725 | Cytal Wound Matrix 3-Layer | Acell, Inc. | 2019-10-25 | 28 | 0 |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | Acell, Inc. | 2019-02-07 | 170 | 0 |
| K180776 | Cytal Wound Particulate | Acell, Inc. | 2018-05-11 | 49 | 0 |
| K172399 | MicroMatrix | Acell, Inc. | 2017-10-06 | 59 | 0 |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Exten | Acell, Inc. | 2017-06-08 | 87 | 0 |
| K162554 | Gentrix Surgical Matrix | Acell, Inc. | 2016-10-21 | 38 | 0 |
| K153754 | MicroMatrix | Acell, Inc. | 2016-03-14 | 76 | 0 |
| K152721 | Cytal Wound Matrix | Acell, Inc. | 2015-12-08 | 78 | 5 |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Flo | Acell, Inc. | 2015-06-17 | 415 | 0 |
| K112409 | MATRISTEM WOUND MATRIX | Acell, Inc. | 2011-08-29 | 7 | 0 |
| K092926 | ACELL MATRISTEM WOUND SHEET | Acell, Inc. | 2009-10-28 | 35 | 0 |
| K060888 | ACELL POWDER WOUND DRESSING | Acell, Inc. | 2006-06-23 | 84 | 0 |
| K041140 | ACELL UBM SURGICAL MESH ML AND MLPLUS | Acell, Inc. | 2004-07-07 | 68 | 0 |
| K040621 | ACELL UBM SURGICAL MESH | Acell, Inc. | 2004-04-14 | 36 | 0 |
| K022854 | ACELL UBM HYDRATED WOUND DRESSING | Acell, Inc. | 2002-12-30 | 137 | 0 |
| K021637 | ACELL UBM LYOPHILIZED WOUND DRESSING | Acell, Inc. | 2002-12-19 | 216 | 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