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 Oct 23, 2017 as substantially equivalent to K141495 (Edwards Lifesciences, LLC, 2014) and 1 other predicate after a 112-day review. Its family tree reaches back 3 generations to 1993. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 23, 2017
- Review
- 112 days
- Class
- Class II
- Product code
- DXO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K925638 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK925638 Phoenix Disposable Pressure Transducer #73-600Baxter Healthcare Corp · 1993 · Recalled
- 2 generations backK141495 Truwave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2014
- 1 generation backK142749 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2015 · Recalled
- This deviceK171996 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2017
- Descendant · cites it directly · 1 of its ownK183413 TruWave Disposable Pressure TransducerEdwards Lifeciences, LLC · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK173586 VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK222216 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK181684 VAMP Plus Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2018 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K183413TruWave Disposable Pressure TransducerEdwards Lifeciences, LLC · 2019 · cites it directly1descendant
- K173586VAMP Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2018 · cites it directly1descendant
- K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2022 · 2 generations on0descendants
- K181684VAMP Plus Venous/Arterial Blood Management Protection SystemEdwards Lifesciences, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925638 | Phoenix Disposable Pressure Transducer #73-600 | Baxter Healthcare Corp | 1993 | 1 |
| −2 | K141495 | Truwave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2014 | — |
| −1 | K142749 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2015 | 11 |
| 0 (this device) | K171996 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2017 | — |
| +1 | K183413 | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | 2019 | 2 |
| +1 | K173586 | VAMP Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2018 | — |
| +2 | K222216 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2022 | — |
| +2 | K181684 | VAMP Plus Venous/Arterial Blood Management Protection System | Edwards Lifesciences, LLC | 2018 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K141495 | Truwave Disposable Pressure TransducerSummary page 4…ducer Classification Name: Transducer, pressure, catheter tip 21 CFR 870.2870 Product Code: DXO, Class II Primary Predicate K141495, Pressure Monitoring Kit with TruWave Disposable Device: Pressure Transducers (cleared 09/03/2014) Secondary Pre… | 2014 |
| * | K142749 | TruWave Disposable Pressure TransducerSummary page 4…imary Predicate K141495, Pressure Monitoring Kit with TruWave Disposable Device: Pressure Transducers (cleared 09/03/2014) Secondary Predicate K142749, TruWave Disposable Pressure Transducer (cleared Device: 01/18/2015) Device Description: The Edwards Lifesci… | 2015 |
What descends from it? (4)
2 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-0413-2024 | Device Design | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K183413 (Edwards Lifeciences, LLC, 2019) has gone furthest, with 1 descendant 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. 2017, 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/K171996 · printed Nov 4, 2026
Cite this page
510(k) Report. “K171996: TruWave Disposable Pressure Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K171996
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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