Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lifecell Corp. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
344 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130817 | LTN - LAPAROSCOPIC SURGICAL MESH | Lifecell Corp. | 2013-04-17 | 23 | 0 |
| K112534 | LIFECELL TISSUE EXPANDER | Lifecell Corp. | 2012-08-10 | 344 | 0 |
| K121289 | LTM-LABAROSCOPIC SURGICAL MESH | Lifecell Corp. | 2012-08-03 | 95 | 0 |
| K082176 | LTM-BPS SURGICAL MESH | Lifecell Corp. | 2008-11-14 | 105 | 0 |
| K082103 | LTM WOUND DRESSING | Lifecell Corp. | 2008-10-08 | 75 | 0 |
| K080353 | LTM-T SURGICAL MESH | Lifecell Corp. | 2008-04-03 | 52 | 0 |
| K071986 | LTM-RC SURGICAL MESH | Lifecell Corp. | 2007-10-19 | 91 | 0 |
| K070560 | LRTM SURGICAL MESH | Lifecell Corp. | 2007-06-11 | 104 | 2 |
| K061208 | LIFECELL DURAL SUBSTITUTE MATRIX | Lifecell Corp. | 2007-01-03 | 247 | 0 |
| K052735 | ALLOCRAFT DBM | Lifecell Corp. | 2005-12-28 | 89 | 2 |
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