510(k) Report

510(k) · Cleared

Cleared

KIM

K103022510(k) TraditionalCleared Dec 20, 2011434-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

Neomedic International S.L. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

Cleared on Dec 20, 2011 as substantially equivalent to K033568 (ETHICON, Inc., 2003) and 4 other predicates after a 434-day review. Its family tree reaches back 10 generations to 2001.

Decided
Dec 20, 2011
Review
434 days
Class
Class II
Product code
OTN
Recalls
None
Predicates
5

Its longest line of descent runs back 10 generations to K011251 (2001). 19 ancestors in all, the oldest K974098 (1998). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2005: 1 other ancestor2003: 1 other ancestor2006: 1 other ancestor1998: 1 other ancestor2002: 1 other ancestor2001: 3 other ancestorsK011251 · 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. · 2008K081275 · Boston Scientific Surgical Mesh · Boston Scientific Corp · 2008K083471 · GMD Universal Sling, Model Product Code 1010 and 1020 · Generic Medical Device, Inc. · 2009 · recalled1995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor K083471 · GMD Universal Sling, Model Product Code 1010 and 1020 · Generic Medical Device, Inc. · 2009 · recalledK081275 · Boston Scientific Surgical Mesh · Boston Scientific Corp · 2008K073703 · 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. · 2001−10−50
  1. Root · 10 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 6 generations between
  3. 3 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
  4. 2 generations backK081275 Boston Scientific Surgical MeshBoston Scientific Corp · 2008
  5. 1 generation backK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · Recalled
  6. This deviceK103022 KIMNeomedic International S.L. · 2011
Show all 10 generations
  1. Root · 10 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 9 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  3. 8 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  4. 7 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  5. 6 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
  6. 5 generations backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
  7. 4 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
  8. 3 generations backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
  9. 2 generations backK081275 Boston Scientific Surgical MeshBoston Scientific Corp · 2008
  10. 1 generation backK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · Recalled
  11. This deviceK103022 KIMNeomedic International S.L. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K011251Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−9K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−8K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−7K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−6K023516Monarc Sling SystemAmerican Medical Systems, Inc.20021
−5K070065Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc.2007—
−4K071902Ams Miniarc Sling SystemAmerican Medical Systems, Inc.2007—
−3K073703Ams Miniarc Sling SystemAmerican Medical Systems, Inc.2008—
−2K081275Boston Scientific Surgical MeshBoston Scientific Corp2008—
−1K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc.20092
0 (this device)K103022KIMNeomedic International S.L.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200130
200210
200310
200510
200610
200810
FIG. 1 — Lineage of K103022, 2001–2011Source: 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? (5)

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
*K033568Gynecare TVT Obturator System
Summary page 1
…hone: (952) 835-4018 DATE PREPARED: December 15", 2011 'DEVICE NAME: KIM (Knotless Incontinence Mesh) CLASSIFICATION Mesh, Surgical, Polymeric NAMES: PREDICATE DEVICES: K033568 Gynecare TVT Obturator System K081275 Boston Scientific Surgical Mesh K072456 Desara Mesh Sting Model CALD-DS01 K083471 GMD Unive…
ETHICON, Inc.2003—
*K081275Boston Scientific Surgical Mesh
Summary page 1
…cember 15", 2011 'DEVICE NAME: KIM (Knotless Incontinence Mesh) CLASSIFICATION Mesh, Surgical, Polymeric NAMES: PREDICATE DEVICES: K033568 Gynecare TVT Obturator System K081275 Boston Scientific Surgical Mesh K072456 Desara Mesh Sting Model CALD-DS01 K083471 GMD Universal Sling Model Product Code 1010 and…
Boston Scientific Corp2008—
*K072456Desara Mesh Sling, Model Cal-DS01
Summary page 1
…less Incontinence Mesh) CLASSIFICATION Mesh, Surgical, Polymeric NAMES: PREDICATE DEVICES: K033568 Gynecare TVT Obturator System K081275 Boston Scientific Surgical Mesh K072456 Desara Mesh Sting Model CALD-DS01 K083471 GMD Universal Sling Model Product Code 1010 and 1020 K052175 I-Stop Mid-Urethral Sling…
Caldera Medical, Inc.2008—
*K083471GMD Universal Sling, Model Product Code 1010 and 1020
Summary page 1
…h, Surgical, Polymeric NAMES: PREDICATE DEVICES: K033568 Gynecare TVT Obturator System K081275 Boston Scientific Surgical Mesh K072456 Desara Mesh Sting Model CALD-DS01 K083471 GMD Universal Sling Model Product Code 1010 and 1020 K052175 I-Stop Mid-Urethral Sling S Device Description: KIM (Knotless Inc…
Generic Medical Device, Inc.20092
*K052175I-Stop Mid-Urethral Sling, Models IS-1000, IS-2000, IS-3000, IS-4000
Summary page 1
…ecare TVT Obturator System K081275 Boston Scientific Surgical Mesh K072456 Desara Mesh Sting Model CALD-DS01 K083471 GMD Universal Sling Model Product Code 1010 and 1020 K052175 I-Stop Mid-Urethral Sling S Device Description: KIM (Knotless Incontinence Mesh) is a sterile, single use surgical mesh kit fo…
Uroplasty, Inc.2005—

Also cleared against K033568: 5 other devices →

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 10 years and passes through 4 companies; a new generation was cleared every 6 months on median.
  • 2 of the 19 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K033568.

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. 2011, 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?

KIM (Knotless Incontinence Mesh) is a surgical mesh kit for treatment of female stress urinary incontinence resulting from urethral hyper mobility 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.

Also cleared against K033568

5 other devices cite the same predicate.

  • K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter…ETHICON, Inc. · 2020
  • K181151GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence SystemETHICON, Inc. · 2018
  • K100936Gynecare TVT Abbrevo Continence SystemETHICON, Inc. · 2010
  • K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 20092 recalls
  • K051533I-STOPCl Medical · 2005

More from Neomedic International S.L.

2 FDA decisions under this applicant name. See the company

  • K120831AnchorsureNeomedic International S.L. · 2012

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/K103022 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103022: KIM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103022

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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