# K243795: pREBOA-PRO Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Prytime Medical Devices, Inc.
- Decided: Sep 5, 2025 after 269 days
- Product code: MJN (Catheter, Intravascular Occluding, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K003495 (2001). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200459: pREBOA-PRO Catheter, Prytime Medical Devices, Inc. (2020) Summary page 5.

## Indications for use
The pREBOA-PRO Catheter is intended for temporary partial or complete occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

Source page: https://510kreport.com/device/K243795
Methodology: https://510kreport.com/methodology