510(k) · Cleared
Recalled · Class II · 2023TruWave Disposable Pressure Transducer
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 Jan 18, 2015 as substantially equivalent to K141495 (Edwards Lifesciences, LLC, 2014) after a 116-day review. Its family tree reaches back 2 generations to 1993. 13 later devices descend from it. It has been recalled 11 times.
- Decided
- Jan 18, 2015
- Review
- 116 days
- Class
- Class II
- Product code
- DXO
- Recalls
- 11
- Predicates
- 1
Its longest line of descent runs back 2 generations to K925638 (1993). 13 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK925638 Phoenix Disposable Pressure Transducer #73-600Baxter Healthcare Corp · 1993 · Recalled
- 1 generation backK141495 Truwave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2014
- This deviceK142749 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2015
- Descendant · cites it directly · 7 of its ownK152980 Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC · 2016 · Recalled
- Descendant · 2 generations on · 6 of its ownK231248 Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs…Edwards Lifesciencess, LLC · 2023 · Recalled
- Descendant · 3 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
- Descendant · cites it directly · 4 of its ownK171996 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2017 · Recalled
- Descendant · 4 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K152980Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC · 2016 · cites it directly7descendants
- K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC · 2023 · 2 generations on6descendants
- K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 3 generations on4descendants
- K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2017 · cites it directly4descendants
- K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere…Edwards Lifesciences · 2025 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925638 | Phoenix Disposable Pressure Transducer #73-600 | Baxter Healthcare Corp | 1993 | 1 |
| −1 | K141495 | Truwave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2014 | — |
| 0 (this device) | K142749 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2015 | — |
| +1 | K152980 | Flo Trac sensor, Volume View sensor | Edwards Lifesciences, LLC | 2016 | 4 |
| +2 | K231248 | Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere… | Edwards Lifesciencess, LLC | 2023 | 2 |
| +3 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)… | Edwards Lifesciences | 2024 | — |
| +1 | K171996 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2017 | 1 |
| +4 | K243781 | HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)… | Edwards Lifesciences | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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? (1)
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 |
|---|---|---|---|
| * | K141495 | Truwave Disposable Pressure TransducerSummary page 4…atheter tip Name 21 CFR 870.2870 Regulation Class II Class/Product DXO Code K141495 - TruWave Disposable Pressure Transducer (Cleared Predicate Device(s) 9/3/2014) Device Description Th… | 2014 |
What descends from it? (13)
See all 133 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 |
|---|---|---|---|---|
| Oct 4, 2023 | Class II | Z-0414-2024 | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. |
| Oct 4, 2023 | Class II | Z-0413-2024 | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. |
| May 26, 2021 | Class II | Z-1960-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1963-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1964-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1961-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1966-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1962-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1965-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| May 26, 2021 | Class II | Z-1959-2021 | Under Investigation by firm | There is a potential that the pressure tubing may detach from the blood sampling system |
| Jul 31, 2015 | Class II | Z-2776-2015 | Device Design | Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 20.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K152980 (Edwards Lifesciences, LLC, 2016) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K141495.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Pressure Monitoring Kit with TruWave Disposable Pressure Transducer is for use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142749 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142749: TruWave Disposable Pressure Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142749
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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