510(k) · Cleared
ClearedRefine Support System, Model 100.0100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alure Medical, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Mar 5, 2010 as substantially equivalent to K083102 (Alure Medical, Inc., 2009) after a 198-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Mar 5, 2010
- Review
- 198 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K992189 (1999). 8 ancestors in all, the oldest K831723 (1983). No later device cites it as a predicate yet.
- Root · 3 generations backK992189 Gore-Tex Dualmesh BiomaterialW. L. Gore & Associates, Inc. · 1999
- 2 generations backK081069 Gore Infinit MeshW. L. Gore & Associates, Inc. · 2008
- 1 generation backK083102 Refine Lift SystemAlure Medical, Inc. · 2009
- This deviceK092538 Refine Support System, Model 100.0100Alure Medical, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K992189 | Gore-Tex Dualmesh Biomaterial | W. L. Gore & Associates, Inc. | 1999 | — |
| −2 | K081069 | Gore Infinit Mesh | W. L. Gore & Associates, Inc. | 2008 | — |
| −1 | K083102 | Refine Lift System | Alure Medical, Inc. | 2009 | — |
| 0 (this device) | K092538 | Refine Support System, Model 100.0100 | Alure Medical, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 2 | 0 |
| 1985 | 1 | 0 |
| 2000 | 1 | 0 |
| 2008 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 |
|---|---|---|---|
| * | K083102 | Refine Lift SystemSummary page 1…Mesh, Surgical, Polymeric, (21 CFR 878.3300, Product Code FTL) Predicate Device Information RefineTrm Support System, K083 102 Product Description The RefineTM Support System consists of a non-absorbable implant and a delivery system. The implant is co… | 2009 |
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 11 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Refine TM Support System is indicated for reinforcement of soft tissue in plastic or reconstructive procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092538: Refine Support System, Model 100.0100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092538
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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