510(k) Report

510(k) · Cleared

Cleared

Minitape Urethral Sling

K091180510(k) SpecialCleared Jul 14, 200982-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. · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Cleared on Jul 14, 2009 as substantially equivalent to K073646 (Mpathy Medical Devices, Ltd., 2008) and 8 other predicates after an 82-day review. Its family tree reaches back 8 generations to 2001. 1 later device descends from it.

Decided
Jul 14, 2009
Review
82 days
Class
Class II
Product code
PAH
Recalls
None
Predicates
9

Its longest line of descent runs back 8 generations to K011251 (2001). 20 ancestors in all, the oldest K945377 (1994). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2002: 4 other ancestors2003: 1 other ancestor2001: 1 other ancestor1998: 2 other ancestors1994: 1 other ancestor2009: 1 descendant cleared×2: 2 generations cleared close together, K011251 (2001), K013355 (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. · 20081990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 2 other ancestors 1 generation forward: 1 descendant K073703 · 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 · 8 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 7 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  3. 6 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  4. 5 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  5. 4 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
  6. 3 generations backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
  7. 2 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
  8. 1 generation backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
  9. This deviceK091180 Minitape Urethral SlingMpathy Medical Devices, Ltd. · 2009
  10. 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

GenerationNumberDeviceApplicantDecidedRecalls
−8K011251Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−7K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−6K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−5K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−4K023516Monarc Sling SystemAmerican Medical Systems, Inc.20021
−3K070065Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc.2007—
−2K071902Ams Miniarc Sling SystemAmerican Medical Systems, Inc.2007—
−1K073703Ams Miniarc Sling SystemAmerican Medical Systems, Inc.2008—
0 (this device)K091180Minitape Urethral SlingMpathy Medical Devices, Ltd.2009—
+1K092203Omnisure 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
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K091180, 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 PAH? 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 PAH device

  1. #1 K242473 Altis Single Incision Sling System (519650)…score 10.9 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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
*K073646Minitape Urethral Sling
Summary page 1
…2009 CLASSIFICATION Surgical Mesh; ref. 21 CFR 878.3300 Product Code . Class |l COMMON NAME Surgical mesh PROPRIETARY Minitape® Urethral Sling NAME PREDICATE DEVICE KO073646 — Modified Minitape Urethral Sling (Mpathy Medical Devices) K020007 - SAFYRE Sling (Comiche, LLC) K033310 - Remeex System (Remeex…
Mpathy Medical Devices, Ltd.2008—
*K020007Safyre Sling System
Summary page 1
…ode . Class |l COMMON NAME Surgical mesh PROPRIETARY Minitape® Urethral Sling NAME PREDICATE DEVICE KO073646 — Modified Minitape Urethral Sling (Mpathy Medical Devices) K020007 - SAFYRE Sling (Comiche, LLC) K033310 - Remeex System (Remeex) K011251, K013355, K021263 & K020663 - SPARC Sling System (American…
Promedon2002—
*K033310Remeex System for Urinary Incontinence
Summary page 1
…sh PROPRIETARY Minitape® Urethral Sling NAME PREDICATE DEVICE KO073646 — Modified Minitape Urethral Sling (Mpathy Medical Devices) K020007 - SAFYRE Sling (Comiche, LLC) K033310 - Remeex System (Remeex) K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K052401 - TVT® Secur…
Specialities Remeex International, S.L.2004—
*K011251Sparc Sling System
Summary page 1
…Sling NAME PREDICATE DEVICE KO073646 — Modified Minitape Urethral Sling (Mpathy Medical Devices) K020007 - SAFYRE Sling (Comiche, LLC) K033310 - Remeex System (Remeex) K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K052401 - TVT® Secur (Gynecare) K073703 - MiniArc® (A…
American Medical Systems, Inc.2001—
*K013355Sparc Sling System
Summary page 1
…AME PREDICATE DEVICE KO073646 — Modified Minitape Urethral Sling (Mpathy Medical Devices) K020007 - SAFYRE Sling (Comiche, LLC) K033310 - Remeex System (Remeex) K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K052401 - TVT® Secur (Gynecare) K073703 - MiniArc® (American M…
American Medical Systems, Inc.2001—
*K021263Modification to Sparc Sling System
Summary page 1
…CATE DEVICE KO073646 — Modified Minitape Urethral Sling (Mpathy Medical Devices) K020007 - SAFYRE Sling (Comiche, LLC) K033310 - Remeex System (Remeex) K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K052401 - TVT® Secur (Gynecare) K073703 - MiniArc® (American Medical Sy…
American Medical Systems, Inc.2002—
*K020663Modification to Sparc Sling System
Summary page 1
…E KO073646 — Modified Minitape Urethral Sling (Mpathy Medical Devices) K020007 - SAFYRE Sling (Comiche, LLC) K033310 - Remeex System (Remeex) K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K052401 - TVT® Secur (Gynecare) K073703 - MiniArc® (American Medical Systems). D…
American Medical Systems, Inc.2002—
*K052401Gynecare TVT Secur System
Summary page 1
…dical Devices) K020007 - SAFYRE Sling (Comiche, LLC) K033310 - Remeex System (Remeex) K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K052401 - TVT® Secur (Gynecare) K073703 - MiniArc® (American Medical Systems). DEVICE The subject device is a surgical mesh. The DESCRI…
ETHICON, Inc.2005—
*K073703Ams Miniarc Sling System
Summary page 1
…Sling (Comiche, LLC) K033310 - Remeex System (Remeex) K011251, K013355, K021263 & K020663 - SPARC Sling System (American Medical Systems) K052401 - TVT® Secur (Gynecare) K073703 - MiniArc® (American Medical Systems). DEVICE The subject device is a surgical mesh. The DESCRIPTION proprietary mesh is suppli…
American Medical Systems, Inc.2008—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092203Omnisure Urethral Sling, Model OTK52Mpathy Medical Devices, Ltd.20090

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 6 months on median.
  • 1 of the 20 ancestors has a recall of any class.
  • Of its descendants, K092203 (Mpathy Medical Devices, Ltd., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All PAH devices

PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · PAH

1in 2024

2007: 22008: 32009: 22010: 12011: 12012: 42020: 12023: 12024: 1
2007high 4 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PAH

128in 2012

2008: 61 days median2012: 128 days median
2007high 128 (2012) · low 61 (2008)2026

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

Recalls per year · PAH

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

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

Adverse event reports per year · PAH

242in 2025

2010: 12011: 72012: 1292013: 2,3862014: 3382015: 2752016: 6972017: 1272018: 1742019: 2982020: 1712021: 3182022: 1592023: 1542024: 2872025: 242
2007high 2,386 (2013) · low 0 (2007)2025

MAUDE reports naming product code PAH, 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
200836100
20092—00
20101—01
20111—07
201241280129
20130—02,386
20140—0338
20150—1275
20160—0697
20170—0127
20180—0174
20190—0298
20201—0171
20210—0318
20220—0159
20231—0154
20241—0287
20250—0242
20260—0—

What is it indicated for?

Minitape 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

  • K092203Omnisure Urethral Sling, Model OTK52Mpathy 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 PAH

The PAH category page

  • K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic…Coloplast Corp. · 2024
  • K221874Altis Single Incision Sling SystemColoplast A/S · 2023
  • K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc. · 2020
  • K121562Altis Single Incision Cling SystemColoplast A/S · 2012
  • K123179Ajust Helical Adjustable Single-Incision SlingC.R. Bard, Inc. · 2012

https://510kreport.com/device/K091180 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091180: Minitape Urethral Sling.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091180

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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