# K142000: Esoflip ES

- Pathway: 510(k) (Traditional)
- Applicant: Crospon, Ltd.
- Decided: Sep 25, 2014 after 64 days
- Product code: PIE (Esophageal Dilator With Balloon And Electrode Sensors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K172128: EsoFLIP® ES-310 Balloon Catheter (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K142000
Methodology: https://510kreport.com/methodology