510(k) · Cleared
Recalled · Class II · 2013Phoenix Disposable Pressure Transducer #73-600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · DXO Transducer, Pressure, Catheter Tip
Cleared on Oct 18, 1993 after a 343-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 16 later devices descend from it. It has been recalled once.
- Decided
- Oct 18, 1993
- Review
- 343 days
- Class
- Class II
- Product code
- DXO
- Recalls
- 1
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK925638 Phoenix Disposable Pressure Transducer #73-600Baxter Healthcare Corp · 1993
- Descendant · cites it directly · 14 of its ownK141495 Truwave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2014
- Descendant · 2 generations on · 13 of its ownK142749 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2015 · Recalled
- Descendant · 3 generations on · 7 of its ownK152980 Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC · 2016 · Recalled
- Descendant · 4 generations on · 6 of its ownK231248 Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs…Edwards Lifesciencess, LLC · 2023 · Recalled
- Descendant · 5 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K141495Truwave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2014 · cites it directly14descendants
- K142749TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2015 · 2 generations on13descendants
- K152980Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC · 2016 · 3 generations on7descendants
- K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC · 2023 · 4 generations on6descendants
- K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925638 | Phoenix Disposable Pressure Transducer #73-600 | Baxter Healthcare Corp | 1993 | — |
| +1 | K141495 | Truwave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2014 | — |
| +2 | K142749 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2015 | 11 |
| +3 | K152980 | Flo Trac sensor, Volume View sensor | Edwards Lifesciences, LLC | 2016 | 4 |
| +4 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere… | Edwards Lifesciencess, LLC | 2023 | 2 |
| +5 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)… | Edwards Lifesciences | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (16)
See all 162 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2013 | Class II | Z-1146-2013 | Process change control | The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K141495 (Edwards Lifesciences, LLC, 2014) has gone furthest, with 14 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 | — |
https://510kreport.com/device/K925638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925638: Phoenix Disposable Pressure Transducer #73-600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925638
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026