510(k) Report

FDA applicant

Lifecell Corp.

Branchburg, NJ15 decisions2005–20204 recalls

FDA records 15 decisions for Lifecell Corp. (Branchburg, NJ) from 2005 to 2020: 15 510(k) clearances. Most are in product codes FTM (Mesh, Surgical) and OXK (Mesh, Surgical, Collagen, Large Abdominal Wall…). Its devices cite 22 predicates, 9 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Lifecell Corporation”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Lifecell Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 32008: 32012: 22013: 12014: 12015: 12017: 22020: 1
2007high 3 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2011

2007: 22010: 12011: 1
2007high 2 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Lifecell Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lifecell Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FTMMesh, Surgical6decisions
  • OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects2decisions
  • MUUSystem, Suction, Lipoplasty2decisions
  • GXQDura Substitute1decision
  • FTLMesh, Surgical, Polymeric1decision
  • KGNWound Dressing With Animal-Derived Material (S)1decision

Also: MBP (1), LCJ (1).

Whose devices does it build on?

Its devices cite 22 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 9 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K070560LRTM Surgical MeshLifecell Corp. · 200710cite it
  • K082176LTM-BPS Surgical MeshLifecell Corp. · 20084cite it
  • K142326HP Tissue MatrixLifecell Corporation · 20142cite it
  • K082103LTM Wound DressingLifecell Corp. · 20082cite it
  • K080353LTM-T Surgical MeshLifecell Corp. · 20081cites it
  • K121289LTM-Labaroscopic Surgical MeshLifecell Corp. · 20121cites it

What has FDA decided for it lately?

  • K193539REVOLVE ENVI 600 Advanced Adipose SystemLifecell Corporation · 2020
  • K163647Revolve Envi 600 Advanced Adipose SystemLifecell Corporation · 2017
  • K162752ARTIA Reconstructive Tissue Matrix PerforatedLifecell Corporation · 2017
  • K150712LTM-Perforated Surgical MeshLifecell Corporation · 2015
  • K142326HP Tissue MatrixLifecell Corporation · 2014
  • K130817LTN - Laparoscopic Surgical MeshLifecell Corp. · 2013
  • K112534Lifecell Tissue ExpanderLifecell Corp. · 2012
  • K121289LTM-Labaroscopic Surgical MeshLifecell Corp. · 2012

All 10 as Lifecell Corp. →All 5 as Lifecell Corporation →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K070560LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008…Jul 13, 2011
  • K070560Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. 8 cm x 8 cm Packaged in…Jul 12, 2010
  • K052735AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876…Oct 17, 2007
  • K052735AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell…Oct 17, 2007