# K183072: EndoFLIP System

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: Feb 15, 2019 after 102 days
- Product code: FFX (System, Gastrointestinal Motility (Electrical))
- Device class: 2
- Regulation: 21 CFR 876.1725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K991288 (1999). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160725: EndoFLIP, Crospon, Ltd. (2016) Summary page 4.

## Most influential descendants
- K223705: EndoflipTM 300 (2023), 1 descendant of its own
- K231861: EndoflipTM 300 System (2023), 0 descendants of its own

## Recalls of this device
- May 13, 2026 · Class II · Z-2950-2026: Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the product unavailable for clinical procedures.

## Indications for use
The Endoflip System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from 5 years of age. It 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/K183072
Methodology: https://510kreport.com/methodology