510(k) · Cleared
ClearedLifecell Tissue Expander
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifecell Corp. · LCJ Tissue Expander And Accessories
Cleared on Aug 10, 2012 as substantially equivalent to K102806 (Allergan Medical, 2011) after a 344-day review. Its family tree reaches back 2 generations to 1986. 2 of the 3 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 10, 2012
- Review
- 344 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K862203 (1986). No later device cites it as a predicate yet. 2 of the 3 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK862203 Mcghan Magna-Site (TM) Tissue ExpanderMcghan Medical Corp. · 1986 · Recalled (Class I)
- 1 generation backK102806 Natrelle 133 Tissue Expander with Suture TabsAllergan Medical · 2011 · Recalled (Class I)
- This deviceK112534 Lifecell Tissue ExpanderLifecell Corp. · 2012
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCJ device
- #1 K254126 Natrelle 133S Tissue Expandersscore 11.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102806 | Natrelle 133 Tissue Expander with Suture TabsSummary page 2…Substantial Equivalence The LifeCell Tissue Expander is substantially equivalent to a legally marketed predicate device, NATRELLE® 133 Tissue Expander with Suture Tabs (K102806). The LifeCell Tissue Expander has the same intended uses and indications for use, and similar technological characteristics and… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 24.5 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All LCJ devicesLCJ Tissue Expander And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LCJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LCJ
525in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCJ
496in 2025
MAUDE reports naming product code LCJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 10 |
| 2008 | 0 | — | 0 | 24 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 0 | — | 0 | 58 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 31 |
| 2013 | 1 | — | 0 | 47 |
| 2014 | 3 | 256 | 0 | 20 |
| 2015 | 2 | — | 0 | 13 |
| 2016 | 3 | 153 | 0 | 38 |
| 2017 | 0 | — | 0 | 111 |
| 2018 | 3 | 29 | 0 | 518 |
| 2019 | 0 | — | 0 | 554 |
| 2020 | 0 | — | 0 | 639 |
| 2021 | 0 | — | 0 | 440 |
| 2022 | 0 | — | 0 | 499 |
| 2023 | 3 | 525 | 1 | 473 |
| 2024 | 1 | — | 0 | 488 |
| 2025 | 2 | — | 0 | 496 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The LifeCell Tissue Expanders are intended for use in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The LifeCell Tissue Expanders are intended for temporary subdermal implantation and are not intended for use beyond six months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112534: Lifecell Tissue Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112534
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026