# K240853: Pathfinder® CR System

- Pathway: 510(k) (Traditional)
- Applicant: Neptune Medical, Inc.
- Decided: Jun 27, 2024 after 91 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K921244 (1992). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211301: Pathfinder Endoscope Overtube, Neptune Medical, Inc. (2021) Summary page 5.
- K232922: Pure-Vu EVS System, Motus GI Medical Technologies, Ltd. (2023) Summary page 6.

## Indications for use
The Pathfinder® CR System is an accessory to the Pathfinder Endoscope Overtube, intended to be used with an endoscope to facilitate evacuation of retained blood, free-floating blood clots, and fluid from the stomach in adult patients (22 years of age or older). It is for use only by medically licensed and trained gastroenterologists located in hospitals, clinics and doctors’ offices.

Source page: https://510kreport.com/device/K240853
Methodology: https://510kreport.com/methodology