510(k) · Cleared

Cleared

Carto XP EP Navigation System

K013083510(k) SpecialCleared Nov 21, 200168-day reviewClass II21 CFR 870.1425

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

Biosense Webster, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Nov 21, 2001 as substantially equivalent to K000248 (Biosense Webster, Inc., 2000) after a 68-day review. Its family tree reaches back 1 generation to 2000. 5 of the 114 devices in its family, counting itself, have a Class I recall. 112 later devices descend from it.

Decided: Nov 21, 2001
Review: 68 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000248 (2000). 112 later devices descend from it, 4 citing it directly. 5 of the 114 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
This deviceK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
Descendant · cites it directly · 101 of its ownK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
Descendant · 2 generations on · 99 of its ownK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
Descendant · 3 generations on · 58 of its ownK070240 Carto XP EP Navigation System, Version 9Biosense Webster, Inc. · 2007
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

Showing 5 of 112 descendants. See all descendants

Descendants cleared per year

2003high 14 (2025) · low 0 (2004)2026

Class I recalls in this family

K190106 Intra-Operative Positioning System; Simple Curve…6 generations on · 2019
K242133 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
K241243 Intra-Operative Positioning System (IOPS®)…7 generations on · 2024
K230309 Intra-Operative Positioning System (IOPS®)…7 generations on · 2023

Most influential descendants

Showing 5 of 112 · See all

K020863Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003 · cites it directly101descendants
K042999Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005 · 2 generations on99descendants
K070240Carto XP EP Navigation System, Version 9Biosense Webster, Inc. · 2007 · 3 generations on58descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000248	Carto EP Navigation System	Biosense Webster, Inc.	2000	—
0 (this device)	K013083	Carto XP EP Navigation System	Biosense Webster, Inc.	2001	—
+1	K020863	Carto XP and Qwikmap EP Navigation System	Biosense Webster, Inc.	2003	—
+2	K042999	Carto XP EP Navigation System, Software Verison 8	Biosense Webster, Inc.	2005	—
+3	K070240	Carto XP EP Navigation System, Version 9	Biosense Webster, Inc.	2007	—
+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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	2	0
2007	2	0
2009	4	0
2010	2	0
2011	3	0
2012	4	0
2013	4	0
2014	7	0
2015	3	0
2016	4	0
2017	3	0
2018	9	0
2019	4	1
2020	6	0
2021	6	0
2022	5	0
2023	8	1
2024	7	2
2025	14	1
2026	13	0

FIG. 1 — Lineage of K013083, 2000–2026Source: 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.

5 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 DQK device

#1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · 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
*	K000248	Carto EP Navigation System Summary page 1 …ry and Clinical Affairs CARTO™ XP EP Navigation System Programmable diagnostic computer (per 21 CFR 870.1425) Cardiac mapping system CARTO™ mapping system 510(k) No. K000248 Biosense Webster (Israel) Ltd. POB 2009 Tirat HaCarmel, 39120 Israel The CARTO™ XP mapping system is designed to acquire, ana…	Biosense Webster, Inc.	2000	—

Also cleared against K000248: 1 other device →

What descends from it? (112)

See all 112

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

Number	Device	Applicant	Decided	Descendants
K020863	Carto XP and Qwikmap EP Navigation System	Biosense Webster, Inc.	2003	101
K072202	Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches…	Biosense Webster, Inc.	2007	47
K063277	Mapmate	Ep Medsystems, Inc.	2006	33
K110878	Rhythmview (TM)	Topera, Inc.	2011	9

Has anything in its family been recalled? (5 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.

K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 6 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 7 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K020863 (Biosense Webster, Inc., 2003) has gone furthest, with 101 descendants of its own.
1 other device also cites its predicate K000248.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

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

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

What is it indicated for?

The intended use of the CARTO XP mapping system is catheter-based atrial and ventricular mapping.

The CARTO XP mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, cardiac chamber geometry maps and cardiac impedance maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

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

https://510kreport.com/device/K013083 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013083: Carto XP EP Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013083

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026