# K132069: Desara Mesh, Desara Blue

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Sep 23, 2013 after 82 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: 6 generations back to K974098 (1998). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112609: Desara Mesh, Caldera Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K140843: Desara Blue OV, Desara Blue SS (2014), 0 descendants of its own

## Indications for use
Desara and Desara Blue are 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/K132069
Methodology: https://510kreport.com/methodology