510(k) · Cleared

Cleared

Carto XP EP Navigation System, Software Verison 8

K042999510(k) TraditionalCleared Mar 21, 2005140-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 Mar 21, 2005 as substantially equivalent to K020863 (Biosense Webster, Inc., 2003) after a 140-day review. Its family tree reaches back 3 generations to 2000. 5 of the 103 devices in its family, counting itself, have a Class I recall. 99 later devices descend from it.

Decided: Mar 21, 2005
Review: 140 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K000248 (2000). 99 later devices descend from it, 3 citing it directly. 5 of the 103 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
2 generations backK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
1 generation backK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
This deviceK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
Descendant · cites it directly · 58 of its ownK070240 Carto XP EP Navigation System, Version 9Biosense 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 · cites it directly · 33 of its ownK063277 MapmateEp Medsystems, Inc. · 2006

Showing 5 of 99 descendants. See all descendants

Descendants cleared per year

2006high 14 (2025) · low 0 (2008)2026

Class I recalls in this family

K190106 Intra-Operative Positioning System; Simple Curve…4 generations on · 2019
K242133 Intra-Operative Positioning System (IOPS®)…5 generations on · 2024
K241243 Intra-Operative Positioning System (IOPS®)…5 generations on · 2024
K230309 Intra-Operative Positioning System (IOPS®)…5 generations on · 2023

Most influential descendants

Showing 5 of 99 · See all

K070240Carto XP EP Navigation System, Version 9Biosense Webster, Inc. · 2007 · cites it directly58descendants
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
K063277MapmateEp Medsystems, Inc. · 2006 · cites it directly33descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000248	Carto EP Navigation System	Biosense Webster, Inc.	2000	—
−2	K013083	Carto XP EP Navigation System	Biosense Webster, Inc.	2001	—
−1	K020863	Carto XP and Qwikmap EP Navigation System	Biosense Webster, Inc.	2003	—
0 (this device)	K042999	Carto XP EP Navigation System, Software Verison 8	Biosense Webster, Inc.	2005	—
+1	K070240	Carto XP EP Navigation System, Version 9	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
+1	K063277	Mapmate	Ep Medsystems, Inc.	2006	—

Descendants by year cleared

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

FIG. 1 — Lineage of K042999, 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? (2)

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
*	K020863	Carto XP and Qwikmap EP Navigation System Summary page 5 …electrograms may also be displayed in real time The intended use of the modified device is the same as for Predicate Device A cleared under 510 (k) Number K020863. The indications for use have been expanded to include CT…	Biosense Webster, Inc.	2003	—
*	—	Siemens Medical System syngo Multimodality Workstation Named without a submission number			—

Also cleared against K020863: 2 other devices →

What descends from it? (99)

See all 99

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

Number	Device	Applicant	Decided	Descendants
K070240	Carto XP EP Navigation System, Version 9	Biosense Webster, Inc.	2007	58
K063277	Mapmate	Ep Medsystems, Inc.	2006	33
K101331	Labsystem Pro EP Recording System V3.1 Software	C.R. Bard Inc., Bard Electrophysiology Division	2010	13

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 · 4 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 · 5 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 · 5 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 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 5 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K070240 (Biosense Webster, Inc., 2007) has gone furthest, with 58 descendants of its own.
2 other devices also cite its predicate K020863.

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, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms…

Read the full statement (128 words)

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, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.

The intended use of the modified device is the same as for Predicate Device A cleared under 510(k) Number K020863. The indications for use have been expanded to include the CARTOMERGE capability to import, register and merge CT or MRI structural images with CARTO maps physiological information and real time catheter navigation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042999 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042999: Carto XP EP Navigation System, Software Verison 8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042999

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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