# Endophys Holdings, LLC

- Location (FDA's records): Dallas, TX
- FDA decisions: 4 (2016–2019): 4 510(k) clearances
- Product codes: DYB (3), DSK (1)
- 510(k) review time since 2016: median 44 days, against 70 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Endophys, Inc.: 3 (https://510kreport.com/company/endophys)

## Firms that cite its devices most
- Endophys Technologies, LLC: 1 (https://510kreport.com/company/endophys-technologies)

## Its most-cited devices
- K160945: Endophys Blood Pressure Monitor (2016), cited by 1
- K173399: Endophys Pressure Sensing Sheath Kit- 8F (2017), cited by 1

## Recent decisions
- K190098: Endophys Pressure Sensing Sheath (Mar 7, 2019)
- K180620: Endophys Pressure Sensing Sheath Kit (Oct 12, 2018)
- K173399: Endophys Pressure Sensing Sheath Kit- 8F (Nov 30, 2017)
- K160945: Endophys Blood Pressure Monitor (Sep 26, 2016)

Source page: https://510kreport.com/company/endophys-holdings