# K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver

- Pathway: 510(k) (Traditional)
- Applicant: Radi Medical Systems AB
- Decided: Jul 1, 2008 after 102 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: 6 generations back to K003122 (2001). 16 ancestors in all.
13 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062769: Pressurewire Certus, Models 12006 and 12306, Radi Medical Systems AB (2006) Summary page 1.
- K972793: Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor Cable, Radi Medical Systems AB (1998) Summary page 1.
- K053016: Wireless Physiologic Monitoring System, Edwards Lifesciences, LLC (2005) Summary page 1.
- K883651: Millar Mikro-Tip Catheter Pressure Transducer, Millar Instruments, Inc. (1988) Summary page 1.

## Most influential descendants
- 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
- K140466: Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300 (2014), 2 descendants of its own
- K111201: C7 XR Imaging System (2011), 2 descendants of its own
- K161171: PressureWire X Guidewire (2016), 1 descendant of its own

## Indications for use
PressureWire® is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessel.

Source page: https://510kreport.com/device/K080813
Methodology: https://510kreport.com/methodology