# K031662: Pressure Wire Sensor, Models 12004/12304

- Pathway: 510(k) (Special)
- Applicant: Radi Medical Systems AB
- Decided: Jun 6, 2003 after 9 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003122 (2001). 7 ancestors in all.
26 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022188: Radianalyzer, Model 12710, Radi Medical Systems AB (2002)

## Most influential descendants
- K062769: Pressurewire Certus, Models 12006 and 12306 (2006), 25 descendants of its own
- K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver (2008), 13 descendants of its own
- K132474: Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter (2014), 10 descendants of its own
- K113584: Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver (2012), 8 descendants of its own
- K131452: Pressurewire; Certus, Certus 300, Aeris, Aeris 300 (2013), 7 descendants of its own

## Indications for use
The Pressurewire Sensor is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary and peripheral blood vessels.

Source page: https://510kreport.com/device/K031662
Methodology: https://510kreport.com/methodology