510(k) · Cleared

Cleared

Truwave Disposable Pressure Transducer

K141495510(k) TraditionalCleared Sep 3, 201489-day reviewClass II21 CFR 870.2870

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Edwards Lifesciences, LLC · DXO Transducer, Pressure, Catheter Tip

Cleared on Sep 3, 2014 as substantially equivalent to K925638 (Baxter Healthcare Corp, 1993) after an 89-day review. Its family tree reaches back 1 generation to 1993. 14 later devices descend from it.

Decided: Sep 3, 2014
Review: 89 days
Class: Class II
Product code: DXO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K925638 (1993). 14 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK925638 Phoenix Disposable Pressure Transducer #73-600Baxter Healthcare Corp · 1993 · Recalled
This deviceK141495 Truwave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2014
Descendant · cites it directly · 13 of its ownK142749 TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2015 · Recalled
Descendant · 2 generations on · 7 of its ownK152980 Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC · 2016 · Recalled
Descendant · 3 generations on · 6 of its ownK231248 Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs…Edwards Lifesciencess, LLC · 2023 · Recalled
Descendant · 4 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

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2015high 4 (2025) · low 0 (2020)2026

Most influential descendants

Showing 5 of 14 · See all

K142749TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2015 · cites it directly13descendants
K152980Flo Trac sensor, Volume View sensorEdwards Lifesciences, LLC · 2016 · 2 generations on7descendants
K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced…Edwards Lifesciencess, LLC · 2023 · 3 generations on6descendants
K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-…Edwards Lifesciences · 2024 · 4 generations on4descendants
K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC · 2017 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925638	Phoenix Disposable Pressure Transducer #73-600	Baxter Healthcare Corp	1993	1
0 (this device)	K141495	Truwave Disposable Pressure Transducer	Edwards Lifesciences, LLC	2014	—
+1	K142749	TruWave Disposable Pressure Transducer	Edwards Lifesciences, LLC	2015	11
+2	K152980	Flo Trac sensor, Volume View sensor	Edwards Lifesciences, LLC	2016	4
+3	K231248	Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere…	Edwards Lifesciencess, LLC	2023	2
+4	K242451	HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)…	Edwards Lifesciences	2024	—
+1	K171996	TruWave Disposable Pressure Transducer	Edwards Lifesciences, LLC	2017	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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

FIG. 1 — Lineage of K141495, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K925638	Phoenix Disposable Pressure Transducer #73-600 Summary page 20 …r, pressure, catheter tip Name 21 CFR 870.2870 Regulation Class/Product Class II Code DXO K925638 - Phoenix Disposable Pressure Transducer #73-600 (Cleared Predicate Device(s) 10/18/1993)…	Baxter Healthcare Corp	1993	1

Also cleared against K925638: 1 other device →

What descends from it? (14)

See all 14

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K142749	TruWave Disposable Pressure Transducer	Edwards Lifesciences, LLC	2015	13
K171996	TruWave Disposable Pressure Transducer	Edwards Lifesciences, LLC	2017	4

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?

Its one ancestor has a recall.
Of its descendants, K142749 (Edwards Lifesciences, LLC, 2015) has gone furthest, with 13 descendants of its own.
1 other device also cites its predicate K925638.

How does its category compare?

All DXO devices

DXO Transducer, Pressure, Catheter Tip: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · DXO

1in 2025

2007high 4 (2019) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXO

120in 2019

2007high 176 (2014) · low 120 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXO

1in 2015

2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DXO

183in 2025

2007high 197 (2024) · low 2 (2008)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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K141495 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141495: 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/K141495

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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