Lifecell Corp.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Lifecell Corp.” (first 2005, latest 2020), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 105 days. Since 2017 the median was 160 days, against 138 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 | 2 | 220 |
| 2013 | 1 | 23 |
| 2014 | 1 | 125 |
| 2015 | 1 | 105 |
| 2016 | 0 | — |
| 2017 | 2 | 196 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 160 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Lifecell Corp. took a median 160 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTM | Mesh, Surgical | 6 | 6 |
| MUU | System, Suction, Lipoplasty | 2 | 2 |
| OXK | Mesh, Surgical, Collagen, Large Abdominal Wall Defects | 2 | 2 |
| FTL | Mesh, Surgical, Polymeric | 1 | 1 |
| GXQ | Dura Substitute | 1 | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
| LCJ | Tissue Expander And Accessories | 1 | 1 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 1 | 1 |
Review panels
- General and Plastic Surgery (13)
- Neurology (1)
- Orthopedic (1)
Most recent Lifecell Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K193539 | REVOLVE ENVI 600 Advanced Adipose System | MUU | 2020-05-28 | 160 |
| K163647 | Revolve Envi 600 Advanced Adipose System | MUU | 2017-08-25 | 245 |
| K162752 | ARTIA Reconstructive Tissue Matrix Perforated | FTM | 2017-02-24 | 147 |
| K150712 | LTM-Perforated Surgical Mesh | FTM | 2015-07-02 | 105 |
| K142326 | HP Tissue Matrix | FTM | 2014-12-23 | 125 |
| K130817 | LTN - LAPAROSCOPIC SURGICAL MESH | OXK | 2013-04-17 | 23 |
| K112534 | LIFECELL TISSUE EXPANDER | LCJ | 2012-08-10 | 344 |
| K121289 | LTM-LABAROSCOPIC SURGICAL MESH | OXK | 2012-08-03 | 95 |
| K082176 | LTM-BPS SURGICAL MESH | FTM | 2008-11-14 | 105 |
| K082103 | LTM WOUND DRESSING | KGN | 2008-10-08 | 75 |
5 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 4 recall events; 0 initiated in the last five years. Most recent: 2011-07-13.
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.
Device clinical trials
An industry sponsor named Lifecell Corp. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00771407: Parastomal Reinforcement With Strattice (Completed, started 2008-12)
- NCT00681291: Strattice in Repair of Inguinal Hernias (Completed, started 2008-04)
- NCT00619762: Immediate Postmastectomy Breast Reconstruction (Strattice Breast) (Completed, started 2007-10)
- NCT00617357: Repair of Infected or Contaminated Hernias (Completed, started 2007-09)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Lifecell Corp. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Lifecell Corp.?
FDA lists 15 510(k) clearances under the applicant name “Lifecell Corp.” (first 2005, latest 2020), across 8 product codes in 3 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 Lifecell Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lifecell Corp. is 105 days. Since 2017: 160 days, versus 138 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Lifecell Corp.?
The most frequent FDA product codes under this applicant name are FTM (Mesh, Surgical, 6); MUU (System, Suction, Lipoplasty, 2); OXK (Mesh, Surgical, Collagen, Large Abdominal Wall Defects, 2).
Next steps
- See all 15 Lifecell Corp. clearances with predicates and recalls
- Run predicate analysis for product code FTM, Lifecell Corp.'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.