510(k) · Cleared
ClearedCui, Versafil (TM), Ste (TM) Tissue Expander
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cox-Uphuff Intl. · FZW Expander, Surgical, Skin Graft
Cleared on Dec 2, 1987 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Dec 2, 1987
- Review
- 43 days
- Class
- Class I
- Product code
- FZW
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K874276 | Cui, Versafil (TM), Ste (TM) Tissue Expander | Cox-Uphuff Intl. | 1987 | — |
| +1 | K973484 | Chin Distractor | Howmedica, Inc. | 1997 | — |
| +2 | K030790 | Osteomed Alveolar Distraction System | Osteomed LP | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FZW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973484 | Chin Distractor | 1997 | 1 |
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?
- Of its descendants, K973484 (Howmedica, Inc., 1997) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FZW devicesFZW Expander, Surgical, Skin Graft: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FZW
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · FZW
Too few FZW 510(k)s in any year since 2007 to give a median.
Recalls per year · FZW
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FZW
433in 2025
MAUDE reports naming product code FZW, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 6 | 3 |
| 2009 | 0 | — | 0 | 72 |
| 2010 | 0 | — | 1 | 51 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 0 | — | 0 | 176 |
| 2014 | 0 | — | 0 | 76 |
| 2015 | 0 | — | 0 | 54 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 0 | — | 0 | 446 |
| 2018 | 0 | — | 0 | 480 |
| 2019 | 0 | — | 0 | 469 |
| 2020 | 0 | — | 0 | 486 |
| 2021 | 0 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 510 |
| 2023 | 0 | — | 0 | 605 |
| 2024 | 0 | — | 0 | 443 |
| 2025 | 0 | — | 0 | 433 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K874276 · printed Nov 5, 2026
Cite this page
510(k) Report. “K874276: Cui, Versafil (TM), Ste (TM) Tissue Expander.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K874276
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026