510(k) Report

510(k) · Cleared

Cleared

Omnisure Urethral Sling, Model OTK52

K092203510(k) SpecialCleared Aug 12, 200921-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mpathy Medical Devices, Ltd. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on Aug 12, 2009 as substantially equivalent to K073647 (Mpathy Medical Devices, Ltd., 2008) and 6 other predicates after a 21-day review. Its family tree reaches back 9 generations to 2001.

Decided
Aug 12, 2009
Review
21 days
Class
Class II
Product code
OTN
Recalls
None
Predicates
7

Its longest line of descent runs back 9 generations to K011251 (2001). 22 ancestors in all, the oldest K945377 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 2 other ancestors1998: 2 other ancestors2005: 1 other ancestor2004: 1 other ancestor2003: 1 other ancestor2002: 4 other ancestors2001: 1 other ancestor1994: 1 other ancestorK011251 · Sparc Sling System · American Medical Systems, Inc. · 2001K013355 · Sparc Sling System · American Medical Systems, Inc. · 2001×2: 2 generations cleared close together, K020663 (2002), K021263 (2002) K023516 · Monarc Sling System · American Medical Systems, Inc. · 2002 · recalledK070065 · Ams Single Incision Sling System (Sis-0) · American Medical Systems, Inc. · 2007K071902 · Ams Miniarc Sling System · American Medical Systems, Inc. · 2007K073703 · Ams Miniarc Sling System · American Medical Systems, Inc. · 2008K091180 · Minitape Urethral Sling · Mpathy Medical Devices, Ltd. · 200919901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 5 other ancestors3 generations back: 4 other ancestors4 generations back: 2 other ancestors K091180 · Minitape Urethral Sling · Mpathy Medical Devices, Ltd. · 2009K073703 · Ams Miniarc Sling System · American Medical Systems, Inc. · 2008K071902 · Ams Miniarc Sling System · American Medical Systems, Inc. · 2007K070065 · Ams Single Incision Sling System (Sis-0) · American Medical Systems, Inc. · 2007K023516 · Monarc Sling System · American Medical Systems, Inc. · 2002 · recalledK021263 · Modification to Sparc Sling System · American Medical Systems, Inc. · 2002K020663 · Modification to Sparc Sling System · American Medical Systems, Inc. · 2002K013355 · Sparc Sling System · American Medical Systems, Inc. · 2001K011251 · Sparc Sling System · American Medical Systems, Inc. · 2001−50
  1. Root · 9 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 5 generations between
  3. 3 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
  4. 2 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
  5. 1 generation backK091180 Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009
  6. This deviceK092203 Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009
Show all 9 generations
  1. Root · 9 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 8 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  3. 7 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  4. 6 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  5. 5 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
  6. 4 generations backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
  7. 3 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
  8. 2 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
  9. 1 generation backK091180 Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009
  10. This deviceK092203 Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K011251Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−8K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−7K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−6K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−5K023516Monarc Sling SystemAmerican Medical Systems, Inc.20021
−4K070065Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc.2007—
−3K071902Ams Miniarc Sling SystemAmerican Medical Systems, Inc.2007—
−2K073703Ams Miniarc Sling SystemAmerican Medical Systems, Inc.2008—
−1K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.2009—
0 (this device)K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199820
200110
200240
200310
200410
200510
200820
FIG. 1 — Lineage of K092203, 2001–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K073647Minitape Extra Urethral Sling
Summary page 1
…Road Glasgow G33 4EL (United Kingdom) 22 July 2009 Surgical Mesh (Product Code OTN) is a Class Il device per 21 CFR 878.3300 Surgical Mesh Omnisure™ Urethral Sling K073647 — Minitape® Extra Urethral Sling (Mpathy Medical Devices) . K011251, K013355, K021263 & K020663 - SPARC Sling System (American Me…
Mpathy Medical Devices, Ltd.2008—
*K011251Sparc Sling System
Summary page 1
…(Product Code OTN) is a Class Il device per 21 CFR 878.3300 Surgical Mesh Omnisure™ Urethral Sling K073647 — Minitape® Extra Urethral Sling (Mpathy Medical Devices) . K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K974098 - TVT (Ethicon) , K091180 - Minitape® O Uret…
American Medical Systems, Inc.2001—
*K013355Sparc Sling System
Summary page 1
…Code OTN) is a Class Il device per 21 CFR 878.3300 Surgical Mesh Omnisure™ Urethral Sling K073647 — Minitape® Extra Urethral Sling (Mpathy Medical Devices) . K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K974098 - TVT (Ethicon) , K091180 - Minitape® O Urethral Slin…
American Medical Systems, Inc.2001—
*K021263Modification to Sparc Sling System
Summary page 1
…) is a Class Il device per 21 CFR 878.3300 Surgical Mesh Omnisure™ Urethral Sling K073647 — Minitape® Extra Urethral Sling (Mpathy Medical Devices) . K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K974098 - TVT (Ethicon) , K091180 - Minitape® O Urethral Sling (Mpathy…
American Medical Systems, Inc.2002—
*K020663Modification to Sparc Sling System
Summary page 1
…ss Il device per 21 CFR 878.3300 Surgical Mesh Omnisure™ Urethral Sling K073647 — Minitape® Extra Urethral Sling (Mpathy Medical Devices) . K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K974098 - TVT (Ethicon) , K091180 - Minitape® O Urethral Sling (Mpathy Medical…
American Medical Systems, Inc.2002—
*K974098Pubouurethral Sling
Summary page 1
…™ Urethral Sling K073647 — Minitape® Extra Urethral Sling (Mpathy Medical Devices) . K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K974098 - TVT (Ethicon) , K091180 - Minitape® O Urethral Sling (Mpathy Medical Devices) Omnisure™ Urethral Sling is a surgical mesh in…
ETHICON, Inc.1998—
*K091180Minitape Urethral Sling
Summary page 1
…Minitape® Extra Urethral Sling (Mpathy Medical Devices) . K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K974098 - TVT (Ethicon) , K091180 - Minitape® O Urethral Sling (Mpathy Medical Devices) Omnisure™ Urethral Sling is a surgical mesh intended to be used as a pubo…
Mpathy Medical Devices, Ltd.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 8 years and passes through 2 companies; a new generation was cleared every 5 months on median.
  • 1 of the 22 ancestors has a recall of any class.

How does its category compare?

All OTN devices

OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · OTN

1in 2023

2007: 22008: 32009: 22010: 52011: 42012: 12013: 52014: 12017: 12019: 12020: 12021: 32022: 22023: 12026 (partial year): 1
2007high 5 (2010) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTN

89in 2021

2008: 100 days median2010: 25 days median2011: 56 days median2013: 86 days median2021: 89 days median
2007high 100 (2008) · low 25 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OTN

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OTN

458in 2025

2010: 12011: 252012: 8742013: 19,0842014: 2,0632015: 3,9042016: 1,9022017: 6762018: 7372019: 2,4572020: 1,0032021: 2,6062022: 8092023: 1,0762024: 8222025: 458
2007high 19,084 (2013) · low 0 (2007)2025

MAUDE reports naming product code OTN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
2008310000
20092—00
201052501
2011456025
20121—0874
2013586019,084
20141—12,063
20150—03,904
20160—01,902
20171—0676
20180—0737
20191—02,457
20201—01,003
202138902,606
20222—0809
20231—01,076
20240—0822
20250—0458
20261—0—

What is it indicated for?

Omnisure™ 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.

More from Mpathy Medical Devices, Ltd.

6 FDA decisions under this applicant name. See the company

  • K091180Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009
  • K073647Minitape Extra Urethral SlingMpathy Medical Devices, Ltd. · 2008
  • K073646Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2008
  • K053361Modification to: Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 20061 recall
  • K041632Minimesh Polypropylene MeshMpathy Medical Devices, Ltd. · 20041 recall

Recent decisions in OTN

The OTN category page

  • K262284Kim BlueDesarrollo e Investigación Médica Aragonesa S.L. · 2026
  • K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemBoston Scientific Corporation · 2023
  • K222293ArcSP Suprapubic Sling SystemUrocure, LLC · 2022
  • K222468ArcTO Transobturator Sling SystemUrocure, LLC · 2022
  • K211975Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 SystemCaldera Medical, Inc. · 2021

https://510kreport.com/device/K092203 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092203: Omnisure Urethral Sling, Model OTK52.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092203

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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