510(k) Report

510(k) · Cleared

Cleared

Swan-Ganz (R) Flow Direct Oximetry/Thermod Cather

K905458510(k) TraditionalCleared Feb 7, 199164-day reviewClass II21 CFR 870.1230

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

Baxter Healthcare Corp · DQE Catheter, Oximeter, Fiber-Optic

Cleared on Feb 7, 1991 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 16 devices in its family, counting itself, has a Class I recall. 15 later devices descend from it.

Decided
Feb 7, 1991
Review
64 days
Class
Class II
Product code
DQE
Recalls
None
Predicates
0

15 later devices descend from it, 2 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1995: 1 descendant cleared2016: 1 descendant cleared, 1 with a Class I recall12020: 1 descendant cleared2023: 1 descendant cleared2024: 3 descendants cleared2022: 1 descendant cleared2026: 3 descendants cleared2025: 4 descendants cleared1990200020102020
  1. This deviceK905458 Swan-Ganz (R) Flow Direct Oximetry/Thermod CatherBaxter Healthcare Corp · 1991
  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 · 2 generations on · 6 of its ownK231248 Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs…Edwards Lifesciencess, LLC · 2023 · Recalled
  5. Descendant · 3 generations on · 4 of its ownK242451 HemoSphere Alta Advanced Monitoring Platform…Edwards Lifesciences · 2024
  6. Descendant · 4 generations on · 2 of its ownK243781 HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module…Edwards Lifesciences · 2025 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1995: 12016: 12020: 12022: 12023: 12024: 32025: 42026: 3
1995high 4 (2025) · low 0 (1996)2026

Class I recalls in this family

  • K160084 Swan Ganz Catheterscites it directly · 2016

Most influential descendants

Showing 5 of 15 · 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
  • 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
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K905458Swan-Ganz (R) Flow Direct Oximetry/Thermod CatherBaxter Healthcare Corp1991—
+1K951566Swan-Ganze Continuous Cardiac Output/Oximetry/Venous Infusion Port/Ejection…Baxter Healthcare Corp1995—
+1K160084Swan Ganz CathetersEdwards Lifesciences, LLC2016Class I
+2K231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere…Edwards Lifesciencess, LLC20232
+3K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1)…Edwards Lifesciences2024—
+4K243781HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10)…Edwards Lifesciences20251

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199510
201611
202010
202210
202310
202430
202540
202630
FIG. 1 — Lineage of K905458, 1991–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (15)

See all 15

2 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

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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

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 DQE devices

DQE Catheter, Oximeter, Fiber-Optic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQE

1in 2018

2009: 12011: 12014: 12016: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQE

Too few DQE 510(k)s in any year since 2007 to give a median.

Recalls per year · DQE

No recall names DQE since 2007.

Adverse event reports per year · DQE

31in 2025

2007: 202008: 122009: 512010: 642011: 542012: 792013: 582014: 382015: 582016: 682017: 472018: 382019: 632020: 392021: 392022: 572023: 482024: 472025: 31
2007high 79 (2012) · low 12 (2008)2025

MAUDE reports naming product code DQE, 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—020
20080—012
20091—051
20100—064
20111—054
20120—079
20130—058
20141—038
20150—058
20161—068
20170—047
20181—038
20190—063
20200—039
20210—039
20220—057
20230—048
20240—047
20250—031
20260—0—

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 DQE

The DQE category page

  • K172423PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter…Edwards Lifescience, LLC · 20181 recall
  • K160645PreSep Oligon Oximetry CatheterEdwards Lifesciences, LLC · 2016
  • K140129Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterIcu Medical, Inc. · 2014
  • K110167Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)Edwards Lifesciences, LLC · 2011
  • K091268Hospira Latex-Free Critical Care and Advanced Sensor CathetersHospira, Inc. · 20095 recalls

https://510kreport.com/device/K905458 · printed Nov 3, 2026

Cite this page

510(k) Report. “K905458: Swan-Ganz (R) Flow Direct Oximetry/Thermod Cather.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K905458

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