# K141615: Endophys Blood Pressure Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Endophys, Inc.
- Decided: Jan 7, 2015 after 205 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: 7 generations back to K003122 (2001). 16 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092105: Radianalyzer Xpress, Radi Medical Systems AB (2009) Summary page 4.
- K132474: Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter, Acist Medical Systems (2014) Summary page 4.

## Most influential descendants
- K160945: Endophys Blood Pressure Monitor (2016), 1 descendant of its own
- K231586: Endophys Blood Pressure Monitor model BPM-30 (2023), 0 descendants of its own

## Indications for use
The Endophys Blood Pressure Monitor is intended for use in a catheterization laboratory to continuously provide systolic, diastolic and mean blood pressure based on the output of the Endophys Pressure Sensing Sheath in patients undergoing therapeutic and/or diagnostic procedures involving percutaneous vascular access.

Source page: https://510kreport.com/device/K141615
Methodology: https://510kreport.com/methodology