510(k) · Cleared
ClearedT-Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Herniamesh S.R.L. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Feb 3, 2006 as substantially equivalent to K020652 (Herniamesh, 2002) and 2 other predicates after a 339-day review. Its family tree reaches back 2 generations to 1998. 13 later devices descend from it.
- Decided
- Feb 3, 2006
- Review
- 339 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K974098 (1998). 5 ancestors in all. 13 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK974098 Pubouurethral SlingETHICON, Inc. · 1998
- 1 generation backK020652 Herniamesh T-SlingHerniamesh · 2002
- This deviceK050516 T-SlingHerniamesh S.R.L. · 2006
- Descendant · cites it directly · 10 of its ownK072456 Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc. · 2008
- Descendant · 2 generations on · 5 of its ownK101169 Desara Mesh Model: Cal-DS01Caldera Medical, Inc. · 2010
- Descendant · 3 generations on · 3 of its ownK112609 Desara MeshCaldera Medical, Inc. · 2011
- Descendant · 2 generations on · 3 of its ownK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 1 of its ownK132069 Desara Mesh, Desara BlueCaldera Medical, Inc. · 2013
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K072456Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc. · 2008 · cites it directly10descendants
- K101169Desara Mesh Model: Cal-DS01Caldera Medical, Inc. · 2010 · 2 generations on5descendants
- K112609Desara MeshCaldera Medical, Inc. · 2011 · 3 generations on3descendants
- K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · 2 generations on3descendants
- K132069Desara Mesh, Desara BlueCaldera Medical, Inc. · 2013 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974098 | Pubouurethral Sling | ETHICON, Inc. | 1998 | — |
| −1 | K020652 | Herniamesh T-Sling | Herniamesh | 2002 | — |
| 0 (this device) | K050516 | T-Sling | Herniamesh S.R.L. | 2006 | — |
| +1 | K072456 | Desara Mesh Sling, Model Cal-DS01 | Caldera Medical, Inc. | 2008 | — |
| +2 | K101169 | Desara Mesh Model: Cal-DS01 | Caldera Medical, Inc. | 2010 | — |
| +3 | K112609 | Desara Mesh | Caldera Medical, Inc. | 2011 | — |
| +2 | K083471 | GMD Universal Sling, Model Product Code 1010 and 1020 | Generic Medical Device, Inc. | 2009 | 2 |
| +4 | K132069 | Desara Mesh, Desara Blue | Caldera Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 OTN? 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 OTN device
- #1 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K020652 | Herniamesh T-SlingSummary page 1…amedical.com Device Name: : Surgical Mesh (878.3300) Trade Name: T-Sling Common Name: Surgioal Mesh Classification: | Class I Predicate Devices: Herniamesh T-Sling ~ K020652 ‘T'yco Healthcare 1VS Tunneller — KO1003S Ethicon 7'V I - K012628 Device Description: The T-Sling is made of monofilament polyp… | 2002 |
| * | K010035 | Ivs Tunneller | 2001 |
| * | K012628 | Gynecare Tension-Free Vaginal Tape SystemSummary page 1…-Sling Common Name: Surgioal Mesh Classification: | Class I Predicate Devices: Herniamesh T-Sling ~ K020652 ‘T'yco Healthcare 1VS Tunneller — KO1003S Ethicon 7'V I - K012628 Device Description: The T-Sling is made of monofilament polypropylene warp knitled into composite mesh construction. ‘T'he T- Sl… | 2001 |
What descends from it? (13)
See all 132 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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K072456 (Caldera Medical, Inc., 2008) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K020652.
How does its category compare?
All OTN devicesOTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OTN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OTN
89in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OTN
458in 2025
MAUDE reports naming product code OTN, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 100 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 5 | 25 | 0 | 1 |
| 2011 | 4 | 56 | 0 | 25 |
| 2012 | 1 | — | 0 | 874 |
| 2013 | 5 | 86 | 0 | 19,084 |
| 2014 | 1 | — | 1 | 2,063 |
| 2015 | 0 | — | 0 | 3,904 |
| 2016 | 0 | — | 0 | 1,902 |
| 2017 | 1 | — | 0 | 676 |
| 2018 | 0 | — | 0 | 737 |
| 2019 | 1 | — | 0 | 2,457 |
| 2020 | 1 | — | 0 | 1,003 |
| 2021 | 3 | 89 | 0 | 2,606 |
| 2022 | 2 | — | 0 | 809 |
| 2023 | 1 | — | 0 | 1,076 |
| 2024 | 0 | — | 0 | 822 |
| 2025 | 0 | — | 0 | 458 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The T-sling is intended to be used in females to position a polypropylene mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050516: T-Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050516
Report an extraction error
Are you the manufacturer?
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