# K991288: Distender Series II Barostat

- Pathway: 510(k) (Traditional)
- Applicant: G & J Electronics, Inc.
- Decided: Jun 8, 1999 after 55 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
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 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
- K092850: Endoflip (2009), 9 descendants of its own
- K120997: Barostat Software Option (2012), 7 descendants of its own
- 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

## Indications for use
The G&J Elactronics Distender Series || Dual Drive Barostal device with the Protocol Plus software is an electro-pnuematic device used for volume/pressure measurement in tho alimentrary tract. This device is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

Source page: https://510kreport.com/device/K991288
Methodology: https://510kreport.com/methodology