# K200459: pREBOA-PRO Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Prytime Medical Devices, Inc.
- Decided: Jun 3, 2020 after 99 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: 7 generations back to K003495 (2001). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172790: ER-REBOA Catheter, Prytime Medical Devices, Inc. (2017) Summary page 4.

## Most influential descendants
- K243795: pREBOA-PRO Catheter (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K200459
Methodology: https://510kreport.com/methodology