# K170133: FFR V2.5

- Pathway: 510(k) (Traditional)
- Applicant: Philips Volcano
- Decided: May 26, 2017 after 129 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K934139 (1995). 49 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150441: Volcano iFR Modality, iFR Scout feature, Volcano Corporation (2015) Summary page 4.

## Most influential descendants
- K173860: s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System (2018), 4 descendants of its own
- K190078: IntraSight (2019), 2 descendants of its own
- K253714: IntraSight Plus (2026), 0 descendants of its own
- K233948: Provisio™ SLT IVUS™ System (2024), 0 descendants of its own
- K203719: IntraSight Mobile (2021), 0 descendants of its own

## Recalls of this device
- Nov 7, 2018 · Class II · Z-0674-2020: Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).

## Indications for use
FFR v2.5 Modality of the s5/s5i/CORE and CORE Mobile Precision Guided Therapy System is indicated in all blood vessels, including coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and/or interventional procedures. The iFR® Modality is intended to be used in conjunction with currently marketed Volcano pressure wires.

Source page: https://510kreport.com/device/K170133
Methodology: https://510kreport.com/methodology