510(k) · Cleared
ClearedTruWave 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 Dec 22, 2022 as substantially equivalent to K183413 (Edwards Lifeciences, LLC, 2019) after a 150-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Dec 22, 2022
- Review
- 150 days
- Class
- Class II
- Product code
- DXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K925638 (1993). No later device cites it as a predicate yet.
- Root · 5 generations backK925638 Phoenix Disposable Pressure Transducer #73-600Baxter Healthcare Corp · 1993 · Recalled
- 4 generations backK141495 Truwave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2014
- 3 generations backK142749 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2015 · Recalled
- 2 generations backK171996 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2017 · Recalled
- 1 generation backK183413 TruWave Disposable Pressure TransducerEdwards Lifeciences, LLC · 2019 · Recalled
- This deviceK222216 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K925638 | Phoenix Disposable Pressure Transducer #73-600 | Baxter Healthcare Corp | 1993 | 1 |
| −4 | K141495 | Truwave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2014 | — |
| −3 | K142749 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2015 | 11 |
| −2 | K171996 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2017 | 1 |
| −1 | K183413 | TruWave Disposable Pressure Transducer | Edwards Lifeciences, LLC | 2019 | 2 |
| 0 (this device) | K222216 | TruWave Disposable Pressure Transducer | Edwards Lifesciences, LLC | 2022 | — |
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 |
|---|---|---|---|
| * | K183413 | TruWave Disposable Pressure TransducerSummary page 4…r Regulation Number/ Regulation 21 CFR 870.2870 / Transducer, Pressure, Catheter Tip Name Product Code DXO Regulation Class Class II Predicate Device K183413- TruWave Disposable Pressure Transducer (cleared 01 May 2019) The TruWave Disposable Pressure Transducer is a… | 2019 |
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 29 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 5 ancestors have a recall of any class.
How does its category compare?
All DXO devicesDXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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/K222216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222216: 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/K222216
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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