510(k) · Cleared
ClearedMinitape Extra Urethral Sling
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mpathy Medical Devices, Ltd. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on Mar 3, 2008 as substantially equivalent to K023898 (Gyne Ideas, Ltd., 2003) and 2 other predicates after a 68-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.
- Decided
- Mar 3, 2008
- Review
- 68 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K011251 (2001). 13 ancestors in all, the oldest K945377 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 4 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 3 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 2 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 1 generation backK023898 Gyne Ideas Minitape RP DeviceGyne Ideas, Ltd. · 2003
- This deviceK073647 Minitape Extra Urethral SlingMpathy Medical Devices, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK092203 Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009
Most influential descendants
Showing 1 of 1 · See all- K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −4 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −3 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −2 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −1 | K023898 | Gyne Ideas Minitape RP Device | Gyne Ideas, Ltd. | 2003 | — |
| 0 (this device) | K073647 | Minitape Extra Urethral Sling | Mpathy Medical Devices, Ltd. | 2008 | — |
| +1 | K092203 | Omnisure Urethral Sling, Model OTK52 | Mpathy Medical Devices, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K023898 | Gyne Ideas Minitape RP DeviceSummary page 1…s J. Mazzarese U.S. Agent for Mpathy Medical Devices Ltd December 18, 2007 Surgical Mesh; ref. 21 CFR 878.3300 Class I Urethral Sling Minitape* Extra Urethral Sling K023898 - Minitape RP™ Urethral Sling (Mpathy Medical Devices) B K020007 - SAFYRE Sling (Corniche, LLC) K021263 - SPARC Sling System (A… | 2003 |
| * | K020007 | Safyre Sling SystemSummary page 1…18, 2007 Surgical Mesh; ref. 21 CFR 878.3300 Class I Urethral Sling Minitape* Extra Urethral Sling K023898 - Minitape RP™ Urethral Sling (Mpathy Medical Devices) B K020007 - SAFYRE Sling (Corniche, LLC) K021263 - SPARC Sling System (American Medical Systems) The subject device is a totally disposab… | 2002 |
| * | K021263 | Modification to Sparc Sling SystemSummary page 1…8.3300 Class I Urethral Sling Minitape* Extra Urethral Sling K023898 - Minitape RP™ Urethral Sling (Mpathy Medical Devices) B K020007 - SAFYRE Sling (Corniche, LLC) K021263 - SPARC Sling System (American Medical Systems) The subject device is a totally disposable mesh tape intended to be used as a pu… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092203 | Omnisure Urethral Sling, Model OTK52 | 2009 | 0 |
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 7 years and passes through 3 companies; a new generation was cleared every 5 months on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K092203 (Mpathy Medical Devices, Ltd., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K023898.
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. 2008, this device’s year, is highlighted.
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 Minitape* Extra Urethral Sling is indicated for the surgical treatment of urodynamically proven female urinary stress incontinence resulting from urethral hypermobility and/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/K073647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073647: Minitape Extra Urethral Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073647
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