# K103022: KIM

- Pathway: 510(k) (Traditional)
- Applicant: Neomedic International S.L.
- Decided: Dec 20, 2011 after 434 days
- Product code: OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K011251 (2001). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033568: Gynecare TVT Obturator System, ETHICON, Inc. (2003) Summary page 1.
- K081275: Boston Scientific Surgical Mesh, Boston Scientific Corp (2008) Summary page 1.
- K072456: Desara Mesh Sling, Model Cal-DS01, Caldera Medical, Inc. (2008) Summary page 1.
- K083471: GMD Universal Sling, Model Product Code 1010 and 1020, Generic Medical Device, Inc. (2009) Summary page 1.
- K052175: I-Stop Mid-Urethral Sling, Models IS-1000, IS-2000, IS-3000, IS-4000, Uroplasty, Inc. (2005) Summary page 1.

## Indications for use
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

Source page: https://510kreport.com/device/K103022
Methodology: https://510kreport.com/methodology