# K250632: Arctx Cool Catheter Set

- Pathway: 510(k) (Traditional)
- Applicant: Arctx Medical
- Decided: Oct 30, 2025 after 241 days
- Product code: PLA (Esophageal Thermal Regulation And Gastric Suctioning Device)
- Device class: 2
- Regulation: 21 CFR 870.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K852698 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170029: FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile, International Biophysics Corporation (2017) Summary page 5.

## Indications for use
The Arctx Cool Catheter Set is a thermal regulating device, intended to: connect to a Blanketrol III Hyper-Hypothermia System to control patient temperature, allow enteral administration of fluids, and provide gastric decompression and suctioning.

Source page: https://510kreport.com/device/K250632
Methodology: https://510kreport.com/methodology