510(k) Report

510(k) · Cleared

Cleared

I-STOP

K051533510(k) TraditionalCleared Aug 11, 200563-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

Cl Medical · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on Aug 11, 2005 as substantially equivalent to K012628 (Gynecare Center, 2001) and 5 other predicates after a 63-day review. Its family tree reaches back 5 generations to 2001. 1 later device descends from it.

Decided
Aug 11, 2005
Review
63 days
Class
Class II
Product code
OTN
Recalls
None
Predicates
6

Its longest line of descent runs back 5 generations to K011251 (2001). 14 ancestors in all, the oldest K974098 (1998). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2004: 2 other ancestors2003: 2 other ancestors2001: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors2006: 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 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 5 other ancestors 1 generation forward: 1 descendant K023516 · 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 · 5 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 4 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  3. 3 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  4. 2 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  5. 1 generation backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
  6. This deviceK051533 I-STOPCl Medical · 2005
  7. Descendant · cites it directly · 0 of its ownK063079 I-Stop Trans Obturator Male SlingCl Medical · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K063079I-Stop Trans Obturator Male SlingCl Medical · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K011251Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−4K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−3K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−2K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−1K023516Monarc Sling SystemAmerican Medical Systems, Inc.20021
0 (this device)K051533I-STOPCl Medical2005—
+1K063079I-Stop Trans Obturator Male SlingCl Medical2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
200110
200320
200420
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K051533, 2001–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (6)

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
*K012628Gynecare Tension-Free Vaginal Tape System
Summary page 1
…78.59.89.78 Vincent GORIA June 1st, 2005 Surgical mesh, Sling, Urethral Sling I-STOP Surgical mesh, polymeric (21 CFR 878.3300) OTN Class |l - Gynecare TVT System: K012628 - SPARC Sling System: K013355 - MONARC Sling System: K023516 - Gynecare TVT-O System: K033568 - Uretex TO: K041176 - Mentor…
Gynecare Center2001—
*K013355Sparc Sling System
Summary page 1
…e 1st, 2005 Surgical mesh, Sling, Urethral Sling I-STOP Surgical mesh, polymeric (21 CFR 878.3300) OTN Class |l - Gynecare TVT System: K012628 - SPARC Sling System: K013355 - MONARC Sling System: K023516 - Gynecare TVT-O System: K033568 - Uretex TO: K041176 - Mentor ARIS TOT: K050148 I-STOP is a…
American Medical Systems, Inc.2001—
*K023516Monarc Sling System
Summary page 1
…g, Urethral Sling I-STOP Surgical mesh, polymeric (21 CFR 878.3300) OTN Class |l - Gynecare TVT System: K012628 - SPARC Sling System: K013355 - MONARC Sling System: K023516 - Gynecare TVT-O System: K033568 - Uretex TO: K041176 - Mentor ARIS TOT: K050148 I-STOP is a sterile, single use kit consisti…
American Medical Systems, Inc.20021
*K033568Gynecare TVT Obturator System
Summary page 1
…mesh, polymeric (21 CFR 878.3300) OTN Class |l - Gynecare TVT System: K012628 - SPARC Sling System: K013355 - MONARC Sling System: K023516 - Gynecare TVT-O System: K033568 - Uretex TO: K041176 - Mentor ARIS TOT: K050148 I-STOP is a sterile, single use kit consisting of one sling of knitted monofil…
ETHICON, Inc.2003—
*K041176Uretex to Trans-Obturator Urethral Support System
Summary page 1
…FR 878.3300) OTN Class |l - Gynecare TVT System: K012628 - SPARC Sling System: K013355 - MONARC Sling System: K023516 - Gynecare TVT-O System: K033568 - Uretex TO: K041176 - Mentor ARIS TOT: K050148 I-STOP is a sterile, single use kit consisting of one sling of knitted monofilament polypropylene,…
Sofradim Production2004—
*K050148Mentor Aris Trans-Obturator Tape and Surgical Kit
Summary page 1
…- Gynecare TVT System: K012628 - SPARC Sling System: K013355 - MONARC Sling System: K023516 - Gynecare TVT-O System: K033568 - Uretex TO: K041176 - Mentor ARIS TOT: K050148 I-STOP is a sterile, single use kit consisting of one sling of knitted monofilament polypropylene, two to four stain The differ…
Mentor Corporation2005—

Also cleared against K012628: 3 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K063079I-Stop Trans Obturator Male SlingCl Medical20060

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 4 years and passes through 2 companies; a new generation was cleared every 5 months on median.
  • 1 of the 14 ancestors has a recall of any class.
  • Of its descendants, K063079 (Cl Medical, 2006) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K012628.

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.

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?

I-STOP® is intended to be used as a pubo-urethral sling for the treatment of female urinary incontinence.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K012628

3 other devices cite the same predicate.

  • K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter…ETHICON, Inc. · 2020
  • K173162GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid…ETHICON, Inc. · 2018
  • K050516T-SlingHerniamesh S.R.L. · 2006

More from Cl Medical

2 FDA decisions under this applicant name. See the company

  • K063079I-Stop Trans Obturator Male SlingCl Medical · 2006

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/K051533 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051533: I-STOP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051533

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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