# K120997: Barostat Software Option

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: Aug 27, 2012 after 147 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991288 (1999). 3 ancestors in all.
7 later devices descend from it; 3 cite 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)
- K991288: Distender Series II Barostat, G & J Electronics, Inc. (1999) Summary page 1.
- K092850: Endoflip, Crospon, Ltd. (2009) Summary page 1.

## Most influential descendants
- K160725: EndoFLIP (2016), 4 descendants of its own
- K183072: EndoFLIP System (2019), 2 descendants of its own
- K223705: EndoflipTM 300 (2023), 1 descendant of its own
- K231861: EndoflipTM 300 System (2023), 0 descendants of its own
- K170833: EndoFLIP® System with FLIP Topography module (2017), 0 descendants of its own

## Indications for use
The EndoFLIP system is indicated for use in a clinical setting as a pressure and dimension measurement device and as an adjunct to other methods in the comprehensive evaluation of patients with symptoms consistent with esophageal sensory hypersensitivity.

Source page: https://510kreport.com/device/K120997
Methodology: https://510kreport.com/methodology