510(k) Report

510(k) · Cleared

Recalled · 2009

Swan-Ganz Continuous Cardiac Output/Oximetry/Venous Port

K934742510(k) TraditionalCleared Jan 24, 1994112-day reviewClass II21 CFR 870.1240Recalls 2

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

Baxter Healthcare Corp · DYG Catheter, Flow Directed

Cleared on Jan 24, 1994 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 29 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it. It has been recalled 2 times.

Decided
Jan 24, 1994
Review
112 days
Class
Class II
Product code
DYG
Recalls
2
Predicates
0

28 later devices descend from it, 3 citing it directly. 2 of the 29 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2003: 2 descendants cleared1995: 1 descendant cleared2016: 1 descendant cleared, 1 with a Class I recall12020: 1 descendant cleared2023: 2 descendants cleared2024: 3 descendants cleared2022: 2 descendants cleared2026: 4 descendants cleared2010: 1 descendant cleared2013: 2 descendants cleared2025: 5 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared, 1 with a Class I recall12014: 1 descendant cleared2017: 1 descendant cleared1990200020102020
  1. This deviceK934742 Swan-Ganz Continuous Cardiac Output/Oximetry/Venous PortBaxter Healthcare Corp · 1994
  2. Descendant · cites it directly · 14 of its ownK951566 Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion…Baxter Healthcare Corp · 1995
  3. Descendant · cites it directly · 13 of its ownK160084 Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · Recalled (Class I)
  4. Descendant · cites it directly · 12 of its ownK021174 Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003
  5. Descendant · 2 generations on · 11 of its ownK032491 Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003
  6. Descendant · 3 generations on · 8 of its ownK094054 Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

1995: 12003: 22010: 12011: 12012: 12013: 22014: 12016: 12017: 12020: 12022: 22023: 22024: 32025: 52026: 4
1995high 5 (2025) · low 0 (1996)2026

Class I recalls in this family

  • K160084 Swan Ganz Catheterscites it directly · 2016
  • K112686 Next Gen Emg Endotracheal Tube4 generations on · 2012

Most influential descendants

Showing 5 of 28 · See all
  • K951566Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection…Baxter Healthcare Corp · 1995 · cites it directly14descendants
  • K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · cites it directly13descendants
  • K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical · 2003 · cites it directly12descendants
  • K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc. · 2003 · 2 generations on11descendants
  • K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc. · 2010 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934742Swan-Ganz Continuous Cardiac Output/Oximetry/Venous PortBaxter Healthcare Corp1994—
+1K951566Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection…Baxter Healthcare Corp1995—
+1K160084Swan Ganz CathetersEdwards Lifesciences, LLC2016Class I
+1K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical2003—
+2K032491Ecom CV4 Endotracheal Cardiac Output MonitorImagyn Medical Technologies, Inc.2003—
+3K094054Modifcation to: Nuvasive Neurovision Emg Endotracheal TubeNuvasive, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199510
200320
201010
201110
201211
201320
201410
201611
201710
202010
202220
202320
202430
202550
202640
FIG. 1 — Lineage of K934742, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

2 devices in this family have a Class I recall. 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 DYG device

  1. #1 K242451 HemoSphere Alta Advanced Monitoring Platform…score 24.2 · 39 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K951566Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection…Baxter Healthcare Corp199514
K160084Swan Ganz Catheters Class IEdwards Lifesciences, LLC201613
K021174Ecom Endotrachial Cardiac Output MonitorImagyn Surgical200312

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 9, 2009Not classifiedZ-1243-2009Software designCardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".
Feb 9, 2009Not classifiedZ-1242-2009Software designCardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K160084Swan Ganz CathetersEdwards Lifesciences, LLC · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 14 Class I recalls
  • K112686Next Gen Emg Endotracheal TubeMedtronic Xomed, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K951566 (Baxter Healthcare Corp, 1995) has gone furthest, with 14 descendants of its own.

How does its category compare?

All DYG devices

DYG Catheter, Flow Directed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYG

3in 2024

2008: 12011: 12016: 12020: 12022: 12023: 12024: 3
2007high 3 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYG

188in 2024

2024: 188 days median
2007high 188 (2024)2026

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

Recalls per year · DYG

2in 2019

2007: 12009: 32013: 12018: 4, 4 Class I2019: 22026 (partial year): 2
2007high 4 (2018) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DYG

268in 2025

2007: 1682008: 4002009: 1452010: 1472011: 2492012: 2212013: 1492014: 1782015: 1632016: 1542017: 1152018: 1332019: 1442020: 1042021: 972022: 1302023: 2292024: 2262025: 268
2007high 400 (2008) · low 97 (2021)2025

MAUDE reports naming product code DYG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—1168
20081—0400
20090—3145
20100—0147
20111—0249
20120—0221
20130—1149
20140—0178
20150—0163
20161—0154
20170—0115
20180—4 (4)133
20190—2144
20201—0104
20210—097
20221—0130
20231—0229
202431880226
20250—0268
20260—2—

More from Baxter Healthcare Corp

590 FDA decisions under this applicant name. See the company

  • P990009/S077Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal…Baxter Healthcare Corp · 2025
  • P990009/S076Floseal Matrix/Floseal Matrix Hemostatic Sealant/Proceed Hemostatic SealantBaxter Healthcare Corp · 2025
  • P990009/S075Floseal Hemostatic MatrixBaxter Healthcare Corp · 2025
  • P050011/S009Adept Adhesion Reduction SolutionBaxter Healthcare Corp · 2024
  • P990009/S074Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast PrepBaxter Healthcare Corp · 2024

Recent decisions in DYG

The DYG category page

  • K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure…Edwards Lifesciences · 2024
  • K233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing…Edwards Lifesciences · 20241 recall
  • K233824Swan-Ganz catheterEdwards Lifesciences, LLC · 20241 recall
  • K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLC · 20232 recalls
  • K222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLC · 2022

https://510kreport.com/device/K934742 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934742: Swan-Ganz Continuous Cardiac Output/Oximetry/Venous Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934742

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026