510(k) · Cleared

Cleared

Refstar External Reference Patch

K061468510(k) SpecialCleared Aug 14, 200680-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

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

Cleared on Aug 14, 2006 as substantially equivalent to K982415 (Cordis Webster, Inc., 1998) after an 80-day review. Its family tree reaches back 1 generation to 1998. 49 later devices descend from it.

Decided: Aug 14, 2006
Review: 80 days
Class: Class II
Product code: DRF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K982415 (1998). 49 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK982415 Cordis Webster Ref-Star External Reference Patch, Model # D-1210Cordis Webster, Inc. · 1998
This deviceK061468 Refstar External Reference PatchBiosense Webster, Inc. · 2006
Descendant · cites it directly · 47 of its ownK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
Descendant · 2 generations on · 45 of its ownK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
Descendant · 3 generations on · 34 of its ownK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
Descendant · 4 generations on · 33 of its ownK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
Descendant · 5 generations on · 32 of its ownK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2007high 7 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 49 · See all

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
K112007Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · 5 generations on32descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K982415	Cordis Webster Ref-Star External Reference Patch, Model # D-1210	Cordis Webster, Inc.	1998	—
0 (this device)	K061468	Refstar External Reference Patch	Biosense Webster, Inc.	2006	—
+1	K072202	Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference…	Biosense Webster, Inc.	2007	—
+2	K090017	Carto 3 EP Navigation System, V1.0 and Accessories	Biosense Webster, Inc.	2009	4
+3	K093455	Carto 3 Version 1.05 EP Navigation System and Accessories	Biosense Webster, Inc.	2009	1
+4	K103746	Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3…	Biosense Webster, Inc.	2011	1
+5	K112007	Carto 3 EP Navigation System, Version 2.2	Biosense Webster, Inc.	2011	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2009	3	0
2010	1	0
2011	2	0
2012	1	0
2013	1	0
2014	2	0
2016	1	0
2017	2	0
2018	5	0
2019	2	0
2020	2	0
2021	2	0
2022	3	0
2023	5	0
2024	4	0
2025	7	0
2026	5	0

FIG. 1 — Lineage of K061468, 1998–2026Source: 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 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 K252794 Vision-MR™ Diagnostic Catheterscore 13.6 · 1 generation · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K982415	Cordis Webster Ref-Star External Reference Patch, Model # D-1210 Summary page 1 …ng Catheter 13.7 CLASSIFICATION Class II 13.8 PREDICATE DEVICE RefStar External Reference Device, K982415, August 10, 1998 22 Biosense Webster…	Cordis Webster, Inc.	1998	—

Also cleared against K982415: 2 other devices →

What descends from it? (49)

See all 49

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

Number	Device	Applicant	Decided	Descendants
K072202	Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches…	Biosense Webster, Inc.	2007	47
K090120	Refstar Plus with Qwikpatch External Reference Patch, Model D-1210-03, Refstar Plus…	Biosense Webster, Inc.	2009	0

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 no recall.
Of its descendants, K072202 (Biosense Webster, Inc., 2007) has gone furthest, with 47 descendants of its own.
2 other devices also cite its predicate K982415.

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

2007high 12 (2021) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRF

45in 2023

2007high 283 (2022) · low 29 (2015)2026

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

Recalls per year · DRF

1in 2015

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	2	120
2008	2	—	4	176
2009	7	243	0	122
2010	5	65	0	130
2011	3	190	6	245
2012	1	—	0	402
2013	2	—	0	310
2014	1	—	2	349
2015	3	29	1	327
2016	8	175	0	383
2017	7	—	0	458
2018	1	—	0	723
2019	10	163	0	669
2020	4	—	0	651
2021	12	124	0	625
2022	8	283	0	613
2023	5	45	0	685
2024	4	—	0	623
2025	3	—	0	508
2026	2	—	0	—

What is it indicated for?

The Biosense Webster RefStar External Reference Patch is indicated for use with Biosense Webster navigation catheters and the CARTO and NOGA Systems to provide a reference point for catheter tip location.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061468 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061468: Refstar External Reference Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061468

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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