# K101462: Ascend Blue AC Mesh; Ascend Blue PC Mesh

- Pathway: 510(k) (Special)
- Applicant: Caldera Medical, Inc.
- Decided: Aug 16, 2010 after 82 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 10 generations back to K931386 (1993). 24 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083722: Ascend, Caldera Medical, Inc. (2009) Summary page 1.

## Most influential descendants
- K120327: Vertessa (2012), 5 descendants of its own
- K123337: Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM (2013), 1 descendant of its own
- K122440: Restorelle L (2012), 1 descendant of its own
- K150016: Vertessa Lite (2015), 0 descendants of its own
- K132061: Restorelle M, Restorelle XL (2013), 0 descendants of its own

## Indications for use
Ascend® Blue AC and Ascend® Blue PC are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.

Source page: https://510kreport.com/device/K101462
Methodology: https://510kreport.com/methodology