# K103418: Desara Mini

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Nov 30, 2011 after 373 days
- Product code: PAH (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling)
- 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: 8 generations back to K011251 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101169: Desara Mesh Model: Cal-DS01, Caldera Medical, Inc. (2010) Summary page 1.
- K073703: Ams Miniarc Sling System, American Medical Systems, Inc. (2008) Summary page 1.

## Indications for use
Desara Mini is intended to be used in females to position a suburethral mesh sling for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence resulting from urethral hypermobility. The mesh is placed transvaginally using a reusable introducer (sold separately)

Source page: https://510kreport.com/device/K103418
Methodology: https://510kreport.com/methodology