# K140843: Desara Blue OV, Desara Blue SS

- Pathway: 510(k) (Special)
- Applicant: Caldera Medical
- Decided: Jul 1, 2014 after 90 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: 7 generations back to K974098 (1998). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132069: Desara Mesh, Desara Blue, Caldera Medical, Inc. (2013) Summary page 1.

## Indications for use
Desara® Blue OV and Desara® Blue SS 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/K140843
Methodology: https://510kreport.com/methodology