# K111854: AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb Receiver

- Pathway: 510(k) (Traditional)
- Applicant: St. Jude Medical Systems AB
- Decided: Oct 21, 2011 after 114 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- 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). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 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 2.
- K080813: Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver, Radi Medical Systems AB (2008) Summary page 2.

## Indications for use
PressureWire Net is intended to condition physiological signals from measuring devices (PressureWire and an external pressure transducer), transmit and receive via radiofrequency, and reconditions the signals to its original format so that those can be displayed on and/or recorded in a receiving device (RadiAnalyzer Xpress or other Monitor systems). The physiological signals can also be distributed via cable. Indication for Use: PressureWire Net is indicated to condition a physiological signal from the cardiovascular systen, transmit and receive via radiofrequency, and recondition the signal to its original format so that it can be displayed. The physiological signal can also be distributed via cable.

Source page: https://510kreport.com/device/K111854
Methodology: https://510kreport.com/methodology