510(k) · Cleared
ClearedAO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb Receiver
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. Jude Medical Systems AB · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Oct 21, 2011 as substantially equivalent to K092105 (Radi Medical Systems AB, 2009) and 1 other predicate after a 114-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Oct 21, 2011
- Review
- 114 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K003122 (2001). 19 ancestors in all, the oldest K883651 (1988). No later device cites it as a predicate yet.
- Root · 7 generations backK003122 Smartflow, Model Sfip 2000Florence Medical, Ltd. · 2001
- 6 generations backK012947 SmartflowFlorence Medical, Ltd. · 2001
- 5 generations backK020127 Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd. · 2002
- 4 generations backK022188 Radianalyzer, Model 12710Radi Medical Systems AB · 2002
- 3 generations backK031662 Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB · 2003
- 2 generations backK062769 Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB · 2006
- 1 generation backK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
- This deviceK111854 AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb…St. Jude Medical Systems AB · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003122 | Smartflow, Model Sfip 2000 | Florence Medical, Ltd. | 2001 | — |
| −6 | K012947 | Smartflow | Florence Medical, Ltd. | 2001 | — |
| −5 | K020127 | Smartflow Pulse Transmission Coefficient | Florence Medical, Ltd. | 2002 | — |
| −4 | K022188 | Radianalyzer, Model 12710 | Radi Medical Systems AB | 2002 | — |
| −3 | K031662 | Pressure Wire Sensor, Models 12004/12304 | Radi Medical Systems AB | 2003 | — |
| −2 | K062769 | Pressurewire Certus, Models 12006 and 12306 | Radi Medical Systems AB | 2006 | — |
| −1 | K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver | Radi Medical Systems AB | 2008 | — |
| 0 (this device) | K111854 | AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb Receiver | St. Jude Medical Systems AB | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DRG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DRG device
- #1 K223711 ANNE Onescore 20.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092105 | Radianalyzer XpressSummary page 2…dition the signal to its can be displayed. The physiological signal can also be distributed via cable. Predicate Devices: * 5 10O(k): K092105 Trade Name: RadiAnalyzer Xpress SE Date: 01/19/2005 Manufa… | 2009 |
| * | K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverSummary page 2…adiAnalyzer Xpress SE Date: 01/19/2005 Manufacturer: Radi Medical Systems AB, Inc. * 510(k) : K080813 Trade Name: PressureWire SE Date: 7/01/2008 Manufacturer:… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- None of the 19 ancestors has a recall.
- 7 other devices also cite its predicate K092105.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (102 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111854: AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb Receiver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111854
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026