510(k) · Cleared
ClearedBiosling - Bioabsorbable Polymer Sling & Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Injectx, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on May 24, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 94 later devices descend from it.
- Decided
- May 24, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
94 later devices descend from it, 5 citing it directly.
- This deviceK010533 Biosling - Bioabsorbable Polymer Sling & Surgical MeshInjectx, Inc. · 2001
- Descendant · cites it directly · 38 of its ownK020110 Modification to Trelex Mesh Surgical MeshBoston Scientific · 2002
- Descendant · cites it directly · 36 of its ownK050332 Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005
- Descendant · 2 generations on · 27 of its ownK041632 Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 19 of its ownK020652 Herniamesh T-SlingHerniamesh · 2002
- Descendant · 2 generations on · 17 of its ownK070894 Tephaflex Surgical MeshTepha, Inc. · 2007
Showing 5 of 94 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 94 · See all- K020110Modification to Trelex Mesh Surgical MeshBoston Scientific · 2002 · cites it directly38descendants
- K050332Surgi-Wrap Mast Bioresorbable SheetMast Biosurgery USA, Inc. · 2005 · cites it directly36descendants
- K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 2004 · 2 generations on27descendants
- K020652Herniamesh T-SlingHerniamesh · 2002 · cites it directly19descendants
- K070894Tephaflex Surgical MeshTepha, Inc. · 2007 · 2 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010533 | Biosling - Bioabsorbable Polymer Sling & Surgical Mesh | Injectx, Inc. | 2001 | — |
| +1 | K020110 | Modification to Trelex Mesh Surgical Mesh | Boston Scientific | 2002 | — |
| +1 | K050332 | Surgi-Wrap Mast Bioresorbable Sheet | Mast Biosurgery USA, Inc. | 2005 | — |
| +2 | K041632 | Minimesh Polypropylene Mesh | Mpathy Medical Devices, Ltd. | 2004 | 1 |
| +1 | K020652 | Herniamesh T-Sling | Herniamesh | 2002 | — |
| +2 | K070894 | Tephaflex Surgical Mesh | Tepha, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 0 |
| 2011 | 10 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (94)
See all 945 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K020110 (Boston Scientific, 2002) has gone furthest, with 38 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 | — |
https://510kreport.com/device/K010533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010533: Biosling - Bioabsorbable Polymer Sling & Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010533
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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