510(k) Report

510(k) · Cleared

Cleared

Sparc Sling System

K011251510(k) TraditionalCleared Aug 1, 200199-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

American Medical Systems, Inc. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on Aug 1, 2001 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 123 later devices descend from it.

Decided
Aug 1, 2001
Review
99 days
Class
Class II
Product code
OTN
Recalls
None
Predicates
0

123 later devices descend from it, 13 citing it directly.

Descendants, by year cleared 2005: 6 descendants cleared2002: 4 descendants cleared2009: 10 descendants cleared2007: 6 descendants cleared2004: 5 descendants cleared2003: 4 descendants cleared2001: 1 descendant cleared2006: 3 descendants cleared2008: 16 descendants cleared2010: 7 descendants cleared2011: 10 descendants cleared2018: 3 descendants cleared2024: 3 descendants cleared2021: 1 descendant cleared2012: 15 descendants cleared2016: 2 descendants cleared2013: 7 descendants cleared2023: 4 descendants cleared2019: 1 descendant cleared2017: 2 descendants cleared2022: 4 descendants cleared2015: 2 descendants cleared2014: 1 descendant cleared2025: 3 descendants cleared2026: 3 descendants cleared200020052010201520202025
  1. This deviceK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. Descendant · cites it directly · 120 of its ownK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  3. Descendant · cites it directly · 110 of its ownK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  4. Descendant · cites it directly · 109 of its ownK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  5. Descendant · cites it directly · 102 of its ownK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
  6. Descendant · cites it directly · 81 of its ownK030123 Bioarc SP Sling KitAmerican Medical Systems, Inc. · 2003

Showing 5 of 123 descendants. See all descendants

Descendants cleared per year

2001: 12002: 42003: 42004: 52005: 62006: 32007: 62008: 162009: 102010: 72011: 102012: 152013: 72014: 12015: 22016: 22017: 22018: 32019: 12021: 12022: 42023: 42024: 32025: 32026: 3
2001high 16 (2008) · low 0 (2020)2026

Most influential descendants

Showing 5 of 123 · See all
  • K013355Sparc Sling SystemAmerican Medical Systems, Inc. · 2001 · cites it directly120descendants
  • K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002 · cites it directly110descendants
  • K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002 · cites it directly109descendants
  • K023516Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · cites it directly102descendants
  • K030123Bioarc SP Sling KitAmerican Medical Systems, Inc. · 2003 · cites it directly81descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011251Sparc Sling SystemAmerican Medical Systems, Inc.2001—
+1K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001—
+1K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
+1K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
+1K023516Monarc Sling SystemAmerican Medical Systems, Inc.20021
+1K030123Bioarc SP Sling KitAmerican Medical Systems, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200240
200340
200450
200560
200630
200760
2008160
2009100
201070
2011100
2012150
201370
201410
201520
201620
201720
201830
201910
202110
202240
202340
202430
202530
202630
FIG. 1 — Lineage of K011251, 2001–2026Source: 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), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (123)

See all 123

13 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001120
K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002110
K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002109
K023516Monarc Sling SystemAmerican Medical Systems, Inc.2002102
K030123Bioarc SP Sling KitAmerican Medical Systems, Inc.200381
K040623Ams Perigee SystemAmerican Medical Systems, Inc.200470
K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.200470
K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc.200610
K020007Safyre Sling SystemPromedon20027
K053296Mentor Aris Suprapubic Surgical KitMentor Corporation20052

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?

  • Of its descendants, K013355 (American Medical Systems, Inc., 2001) has gone furthest, with 120 descendants of its own.

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—

More from American Medical Systems, Inc.

75 FDA decisions under this applicant name. See the company

  • K132655Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
  • K112842Ams Elevate PCAmerican Medical Systems, Inc. · 2011
  • K100807Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc. · 2010
  • K092735Greenlight XPS Laser SystemAmerican Medical Systems, Inc. · 20091 recall
  • K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2009

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/K011251 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011251: Sparc Sling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011251

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026