510(k) Report

510(k) · Cleared

Cleared

Cordis Webster Ref-Star External Reference Patch, Model # D-1210

K982415510(k) SpecialCleared Aug 10, 199828-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 Aug 10, 1998 after a 28-day review. The FDA summary names its predicate without a number. 50 later devices descend from it.

Decided
Aug 10, 1998
Review
28 days
Class
Class II
Product code
DRF
Recalls
None
Predicates
0

50 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2007: 1 descendant cleared2009: 3 descendants cleared2013: 1 descendant cleared2010: 1 descendant cleared2017: 2 descendants cleared2011: 2 descendants cleared2020: 2 descendants cleared2014: 2 descendants cleared2018: 5 descendants cleared2024: 4 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2023: 5 descendants cleared2025: 7 descendants cleared2021: 2 descendants cleared2012: 1 descendant cleared2016: 1 descendant cleared2026: 5 descendants cleared1995200020052010201520202025
  1. This deviceK982415 Cordis Webster Ref-Star External Reference Patch, Model # D-1210Cordis Webster, Inc. · 1998
  2. Descendant · cites it directly · 49 of its ownK061468 Refstar External Reference PatchBiosense Webster, Inc. · 2006
  3. Descendant · cites it directly · 47 of its ownK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
  4. Descendant · 2 generations on · 45 of its ownK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
  5. Descendant · 3 generations on · 34 of its ownK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
  6. Descendant · 4 generations on · 33 of its ownK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12009: 32010: 12011: 22012: 12013: 12014: 22016: 12017: 22018: 52019: 22020: 22021: 22022: 32023: 52024: 42025: 72026: 5
2006high 7 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 50 · See all
  • K061468Refstar External Reference PatchBiosense Webster, Inc. · 2006 · cites it directly49descendants
  • K072202Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches…Biosense Webster, Inc. · 2007 · cites it directly47descendants
  • K090017Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · 2 generations on45descendants
  • K093455Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · 3 generations on34descendants
  • K103746Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation…Biosense Webster, Inc. · 2011 · 4 generations on33descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K982415Cordis Webster Ref-Star External Reference Patch, Model # D-1210Cordis Webster, Inc.1998—
+1K061468Refstar External Reference PatchBiosense Webster, Inc.2006—
+1K072202Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference…Biosense Webster, Inc.2007—
+2K090017Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc.20094
+3K093455Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc.20091
+4K103746Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3…Biosense Webster, Inc.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200930
201010
201120
201210
201310
201420
201610
201720
201850
201920
202020
202120
202230
202350
202440
202570
202650
FIG. 1 — Lineage of K982415, 1998–2026Source: 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), 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 DRF? 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 13.6 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—Ex Surface Reference Device
Named without a submission number
—

What descends from it? (50)

See all 50

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

NumberDeviceApplicantDecidedDescendants
K061468Refstar External Reference PatchBiosense Webster, Inc.200649
K072202Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches…Biosense Webster, Inc.200747
K090120Refstar Plus with Qwikpatch External Reference Patch, Model D-1210-03, Refstar Plus…Biosense Webster, Inc.20090

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?

  • Of its descendants, K061468 (Biosense Webster, Inc., 2006) has gone furthest, with 49 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—

What is it indicated for?

The REF-STAR External Reference Patch is indicated for use with the NAVI-STAR and NOGA-STAR catheters and the CARTO and NOGA systems to provide catheter tip location as well as electrogram information.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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
  • K980961Cordis Webster Ref-Star EX Surface Reference Device Model's D-1204-01, -02,-03, and -04.Cordis Webster, Inc. · 1998
  • K970264Cordis Webster Braided Guiding Sheath Exchange SystemCordis Webster, Inc. · 1997

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/K982415 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982415: Cordis Webster Ref-Star External Reference Patch, Model # D-1210.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982415

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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