# K101169: Desara Mesh Model: Cal-DS01

- Pathway: 510(k) (Special)
- Applicant: Caldera Medical, Inc.
- Decided: May 20, 2010 after 24 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: 4 generations back to K974098 (1998). 7 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072456: Desara Mesh Sling, Model Cal-DS01, Caldera Medical, Inc. (2008) Summary page 1.

## Most influential descendants
- K112609: Desara Mesh (2011), 3 descendants of its own
- K132069: Desara Mesh, Desara Blue (2013), 1 descendant of its own
- K140843: Desara Blue OV, Desara Blue SS (2014), 0 descendants of its own
- K121928: Desara SL (2013), 0 descendants of its own
- K103418: Desara Mini (2011), 0 descendants of its own

## Indications for use
The Desara® Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K101169
Methodology: https://510kreport.com/methodology