510(k) · Cleared
ClearedCaldera Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caldera Medical, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Feb 22, 2006 after a 50-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Feb 22, 2006
- Review
- 50 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK060004 Caldera MeshCaldera Medical, Inc. · 2006
- Descendant · cites it directly · 8 of its ownK101722 Alyte Y-Mesh GraftC.R. Bard, Inc. · 2011
- Descendant · 2 generations on · 6 of its ownK112322 Restorelle Polypropylene Y MeshColoplast A/S · 2012
- Descendant · 3 generations on · 2 of its ownK123914 Restorelle Y ContourColoplast A/S · 2013
- Descendant · 4 generations on · 1 of its ownK140116 Restorelle Y Contour MeshColoplast A/S · 2014
- Descendant · 2 generations on · 1 of its ownK123028 Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc. · 2013
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K101722Alyte Y-Mesh GraftC.R. Bard, Inc. · 2011 · cites it directly8descendants
- K112322Restorelle Polypropylene Y MeshColoplast A/S · 2012 · 2 generations on6descendants
- K123914Restorelle Y ContourColoplast A/S · 2013 · 3 generations on2descendants
- K140116Restorelle Y Contour MeshColoplast A/S · 2014 · 4 generations on1descendant
- K123028Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-MeshCaldera Medical, Inc. · 2013 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060004 | Caldera Mesh | Caldera Medical, Inc. | 2006 | — |
| +1 | K101722 | Alyte Y-Mesh Graft | C.R. Bard, Inc. | 2011 | — |
| +2 | K112322 | Restorelle Polypropylene Y Mesh | Coloplast A/S | 2012 | — |
| +3 | K123914 | Restorelle Y Contour | Coloplast A/S | 2013 | — |
| +4 | K140116 | Restorelle Y Contour Mesh | Coloplast A/S | 2014 | — |
| +2 | K123028 | Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-Mesh | Caldera Medical, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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?
The FDA summary names no predicate by number.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101722 | Alyte Y-Mesh Graft | 2011 | 8 |
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, K101722 (C.R. Bard, Inc., 2011) has gone furthest, with 8 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Caldera Polypropylene Mesh is a mesh sling implant that is intended fbr the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair. reconstruction of the pelvic floor and sacral-colposuspension.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060004: Caldera Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060004
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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