510(k) · Cleared
ClearedWireless Physiologic Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edwards Lifesciences, LLC · DXO Transducer, Pressure, Catheter Tip
Cleared on Dec 30, 2005 after a 65-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.
- Decided
- Dec 30, 2005
- Review
- 65 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 2 citing it directly.
- This deviceK053016 Wireless Physiologic Monitoring SystemEdwards Lifesciences, LLC · 2005
- Descendant · cites it directly · 13 of its ownK080813 Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008
- Descendant · cites it directly · 9 of its ownK090610 Hospira Vital Signs Wireless Monitoring SystemHospira, Inc. · 2009
- Descendant · 2 generations on · 8 of its ownK113584 Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012
- Descendant · 3 generations on · 7 of its ownK131452 Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013
- Descendant · 2 generations on · 6 of its ownK142476 Master Caution Device MCDHealthwatch, Ltd. · 2015
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB · 2008 · cites it directly13descendants
- K090610Hospira Vital Signs Wireless Monitoring SystemHospira, Inc. · 2009 · cites it directly9descendants
- K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical · 2012 · 2 generations on8descendants
- K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB · 2013 · 3 generations on7descendants
- K142476Master Caution Device MCDHealthwatch, Ltd. · 2015 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053016 | Wireless Physiologic Monitoring System | Edwards Lifesciences, LLC | 2005 | — |
| +1 | K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver | Radi Medical Systems AB | 2008 | — |
| +1 | K090610 | Hospira Vital Signs Wireless Monitoring System | Hospira, Inc. | 2009 | — |
| +2 | K113584 | Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver | St Jude Medical | 2012 | — |
| +3 | K131452 | Pressurewire; Certus, Certus 300, Aeris, Aeris 300 | St. Jude Medical Systems AB | 2013 | — |
| +2 | K142476 | Master Caution Device MCD | Healthwatch, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 DXO? 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 DXO device
- #1 K241418 OptoMonitor 3score 14.8 · 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? (4)
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 |
|---|---|---|---|
| * | — | Phoenix Disposable Pressure Transducer #73-600 Named without a submission number | |
| * | — | SurgiChip Tag Surgical Marker Named without a submission number | |
| * | — | M3290A IntelliVue Information Center Software Rel. F.0 and M4840A Telemetry System II… Named without a submission number | |
| * | — | MPT 24 and VitalView 24 Named without a submission number |
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K080813 (Radi Medical Systems AB, 2008) has gone furthest, with 13 descendants of its own.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXO
120in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXO
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXO
183in 2025
MAUDE reports naming product code DXO, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 1 | — | 0 | 74 |
| 2011 | 1 | — | 0 | 111 |
| 2012 | 1 | — | 0 | 82 |
| 2013 | 1 | — | 0 | 93 |
| 2014 | 3 | 176 | 0 | 85 |
| 2015 | 2 | — | 1 | 114 |
| 2016 | 2 | — | 0 | 152 |
| 2017 | 2 | — | 0 | 186 |
| 2018 | 1 | — | 0 | 179 |
| 2019 | 4 | 120 | 0 | 153 |
| 2020 | 2 | — | 0 | 158 |
| 2021 | 0 | — | 0 | 116 |
| 2022 | 1 | — | 0 | 144 |
| 2023 | 0 | — | 0 | 194 |
| 2024 | 1 | — | 0 | 197 |
| 2025 | 1 | — | 0 | 183 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Wireless Physiologic Monitoring System is indicated for use on patients requiring pressure monitoring. The Wireless Physiologic Monitoring System is intended to perform wireless transmission of pressure information to remote patient monitors from disposable pressure transducers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053016: Wireless Physiologic Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053016
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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