# K231586: Endophys Blood Pressure Monitor model BPM-30

- Pathway: 510(k) (Traditional)
- Applicant: Endophys Technologies, LLC
- Decided: Nov 3, 2023 after 156 days
- Product code: DSK (Computer, Blood-Pressure)
- Device class: 2
- Regulation: 21 CFR 870.1110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K003122 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160945: Endophys Blood Pressure Monitor, Endophys Holdings, LLC (2016) Summary page 4.

## Indications for use
The Endophys Blood Pressure Monitor Model BPM-30 is intended to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys PSS3 Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access. The Endophys Blood Pressure Monitor Model BPM-30 monitor is additionally intended for use in transport situations within hospital environments.

Source page: https://510kreport.com/device/K231586
Methodology: https://510kreport.com/methodology