510(k) · Cleared
ClearedAlloX2 Pro Tissue Expanders
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sientra, Inc. · LCJ Tissue Expander And Accessories
Cleared on Jun 8, 2023 as substantially equivalent to K140383 (Specialty Surgical Products, Inc., 2014) after a 525-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Jun 8, 2023
- Review
- 525 days
- Class
- Class U
- Product code
- LCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K801766 (1980). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801766 | Jackson-Pratt Large Vol. Closed Wound | American Heyer Schulte | 1980 | — |
| −1 | K140383 | ALLOX2 Tissue Expanders | Specialty Surgical Products, Inc. | 2014 | — |
| 0 (this device) | K214124 | AlloX2 Pro Tissue Expanders | Sientra, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
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.
Planning a device in LCJ? 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 |
|---|---|---|---|
| * | K140383 | ALLOX2 Tissue ExpandersSummary page 4…cation Name: Expander, Skin, Inflatable Review Panel: General and Plastic Surgery Devices Panel Predicate Device: Sientra AlloX2 Tissue Expander (K140383) Indications for Use [807.92(a)(5)] The Sientra AlloX2 Pro Tissue Expanders are intended for temporary (less than six months) s… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 43 years and passes through 3 companies; a new generation was cleared every 34.2 years on median.
- None of the 3 ancestors has a 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. 2023, 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 Sientra AlloX2 Pro Tissue Expanders are intended for temporary (less than six months) subcutaneous or submuscular implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstructions following mastectomy, to aid in the treatment of underdeveloped breasts and to aid in treatment of soft tissue deformities.
Additionally, the Sientra AlloX2 Pro Tissue Expanders contain a silicone drain component which allows access to and drainage of latent fluids from the periprosthetic space. This drain component does not replace short-term, immediate, intraoperatively placed drains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214124: AlloX2 Pro Tissue Expanders.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214124
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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