Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lifecell Corporation — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
147 daysmedian FDA review time
245 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193539 | REVOLVE ENVI 600 Advanced Adipose System | Lifecell Corporation | 2020-05-28 | 160 | 0 |
| K163647 | Revolve Envi 600 Advanced Adipose System | Lifecell Corporation | 2017-08-25 | 245 | 0 |
| K162752 | ARTIA Reconstructive Tissue Matrix Perforated | Lifecell Corporation | 2017-02-24 | 147 | 0 |
| K150712 | LTM-Perforated Surgical Mesh | Lifecell Corporation | 2015-07-02 | 105 | 0 |
| K142326 | HP Tissue Matrix | Lifecell Corporation | 2014-12-23 | 125 | 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