# K191416: Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 Pack

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Feb 7, 2020 after 255 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K211975: Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System (2021), 0 descendants of its own

## Indications for use
The Desara One mid-urethral mesh implant is intended for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Desara One introducer is intended for the placement of the Desara One single incision mesh implant.

Source page: https://510kreport.com/device/K191416
Methodology: https://510kreport.com/methodology