510(k) Report

510(k) · Cleared

Cleared

Cordis Wester Star Catheter

K954390510(k) TraditionalCleared Dec 21, 199593-day reviewClass II21 CFR 870.1220

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

Cordis Webster, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

Cleared on Dec 21, 1995 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 34 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it.

Decided
Dec 21, 1995
Review
93 days
Class
Class II
Product code
DRF
Recalls
None
Predicates
0

33 later devices descend from it, 5 citing it directly. 2 of the 34 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2008: 1 descendant cleared2007: 1 descendant cleared2009: 5 descendants cleared2005: 1 descendant cleared2006: 1 descendant cleared2011: 4 descendants cleared2018: 1 descendant cleared2024: 4 descendants cleared, 1 with a Class I recall12023: 3 descendants cleared2010: 2 descendants cleared2016: 3 descendants cleared2017: 1 descendant cleared2014: 1 descendant cleared2025: 2 descendants cleared, 1 with a Class I recall12013: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954390 Cordis Wester Star CatheterCordis Webster, Inc. · 1995
  2. Descendant · cites it directly · 14 of its ownK070242 Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc. · 2007
  3. Descendant · 2 generations on · 9 of its ownK092064 Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc. · 2009
  4. Descendant · cites it directly · 7 of its ownK081258 Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc. · 2009
  5. Descendant · cites it directly · 7 of its ownK080425 CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Biosense Webster, Inc. · 2008
  6. Descendant · 2 generations on · 5 of its ownK112050 Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc. · 2011

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 12008: 12009: 52010: 22011: 42013: 12014: 12016: 32017: 12018: 12022: 12023: 32024: 42025: 22026: 1
2005high 5 (2009) · low 0 (2012)2026

Class I recalls in this family

  • K250545 Medline ReNewal Reprocessed Biosense Webster…3 generations on · 2025
  • K241224 Medline ReNewal Reprocessed Biosense Webster…3 generations on · 2024

Most influential descendants

Showing 5 of 33 · See all
  • K070242Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc. · 2007 · cites it directly14descendants
  • K092064Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc. · 2009 · 2 generations on9descendants
  • K081258Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc. · 2009 · cites it directly7descendants
  • K080425CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Biosense Webster, Inc. · 2008 · cites it directly7descendants
  • K112050Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc. · 2011 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954390Cordis Wester Star CatheterCordis Webster, Inc.1995—
+1K070242Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc.2007—
+2K092064Soundstar 3D Ultrasound Catheter, Model M-5723-12Biosense Webster, Inc.2009—
+1K081258Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc.2009—
+1K080425CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Biosense Webster, Inc.2008—
+2K112050Soundstar Eco Diagnostic Ultrasound CatheterBiosense Webster, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200710
200810
200950
201020
201140
201310
201410
201630
201710
201810
202210
202330
202441
202521
202610
FIG. 1 — Lineage of K954390, 1995–2026Source: 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.

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 DRF device

  1. #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.7 · 1 generation · 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K070242Soundstar 3D Ultrasound Catheter, Model M-5723-05Biosense Webster, Inc.200714
K081258Variable Lasso Nav Catheter, Models: D-1290-01, D-1290-02Biosense Webster, Inc.20097
K080425CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02Biosense Webster, Inc.20087
K061463Esophageal Mapping Catheter, Model D-1272-01-SBiosense Webster, Inc.20060
K052083Navistar RMT Steerable Tip Diagnostic CatheterBiosense Webster, Inc.20050

Has anything in its family been recalled? (2 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.

  • K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc. · 2025 · 3 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
  • K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline…Surgical Instrument Service and Savings Inc.(Dba Medline Ren · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • Of its descendants, K070242 (Biosense Webster, Inc., 2007) has gone furthest, with 14 descendants of its own.

How does its category compare?

All DRF devices

DRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRF

3in 2025

2007: 22008: 22009: 72010: 52011: 32012: 12013: 22014: 12015: 32016: 82017: 72018: 12019: 102020: 42021: 122022: 82023: 52024: 42025: 32026 (partial year): 2
2007high 12 (2021) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRF

45in 2023

2009: 243 days median2010: 65 days median2011: 190 days median2015: 29 days median2016: 175 days median2019: 163 days median2021: 124 days median2022: 283 days median2023: 45 days median
2007high 283 (2022) · low 29 (2015)2026

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

Recalls per year · DRF

1in 2015

2007: 22008: 42011: 62014: 22015: 1
2007high 6 (2011) · low 0 (2009)2026

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

Adverse event reports per year · DRF

508in 2025

2007: 1202008: 1762009: 1222010: 1302011: 2452012: 4022013: 3102014: 3492015: 3272016: 3832017: 4582018: 7232019: 6692020: 6512021: 6252022: 6132023: 6852024: 6232025: 508
2007high 723 (2018) · low 120 (2007)2025

MAUDE reports naming product code DRF, 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
20072—2120
20082—4176
200972430122
20105650130
201131906245
20121—0402
20132—0310
20141—2349
20153291327
201681750383
20177—0458
20181—0723
2019101630669
20204—0651
2021121240625
202282830613
20235450685
20244—0623
20253—0508
20262—0—

More from Cordis Webster, Inc.

10 FDA decisions under this applicant name. See the company

  • K992965Cordis Webster Fixed Curve Catheters, Models D-1124, D-1085Cordis Webster, Inc. · 1999
  • K991531Cordis Webster Diagnostic Deflectable Tip Catheter, Model D-1078Cordis Webster, Inc. · 1999
  • K982740Cordis Webster Preface Braided Guiding Sheath & Perry Exchange Dilator, Model #'S 301-803A, 301-803P…Cordis Webster, Inc. · 1998
  • K982415Cordis Webster Ref-Star External Reference Patch, Model # D-1210Cordis Webster, Inc. · 1998
  • K980961Cordis Webster Ref-Star EX Surface Reference Device Model's D-1204-01, -02,-03, and -04.Cordis Webster, Inc. · 1998

Recent decisions in DRF

The DRF category page

  • K262068Khelix Magnetic Sensor Electrophysiology Catheter (SS1-*-*-MAG)CathRx, Ltd. · 2026
  • K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc. · 2026
  • K250590MAGiC Sweep™ EP Mapping CatheterStereotaxis, Inc. · 2025
  • K250310VIKING™ Fixed Curve Diagnostic CatheterBoston Scientific Corporation · 2025
  • P990025/S074NAVISTAR Electrophysiology CatheterBiosense Webster, Inc. · 2025

https://510kreport.com/device/K954390 · printed Nov 4, 2026

Cite this page

510(k) Report. “K954390: Cordis Wester Star Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954390

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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