# K132337: Esoflip Balloon Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: Oct 7, 2013 after 73 days
- Product code: PID (Esophageal Dilator Balloon With Or Without Electrode Sensors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- 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: 3 generations back to K991288 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900924: Wilson-Cook Balloon Dilation Catheters, Wilson-Cook Medical, Inc. (1990) Summary page 4.
- K120997: Barostat Software Option, Crospon, Ltd. (2012) Summary page 4.

## Recalls of this device
- Apr 25, 2024 · Class II · Z-2038-2024: Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to various harms.

## Indications for use
The EsoFLIP® Balloon Dilation Catheter is indicated for use in a clinical setting for dilating the gastro-esophageal junction of a patient with Achalasia.

Source page: https://510kreport.com/device/K132337
Methodology: https://510kreport.com/methodology