510(k) · Cleared

Cleared

Carto System

K954395510(k) TraditionalCleared Dec 21, 199592-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, Ltd. · DQK Computer, Diagnostic, Programmable

Cleared on Dec 21, 1995 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.

Decided: Dec 21, 1995
Review: 92 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 0

57 later devices descend from it, 4 citing it directly.

This deviceK954395 Carto SystemBiosense, Ltd. · 1995
Descendant · cites it directly · 36 of its ownK992968 Carto EP Navigation SystemBiosense Webster, Inc. · 1999
Descendant · 2 generations on · 34 of its ownK993729 Modification to Carto EP Navigation SystemBiosense Webster, Inc. · 1999
Descendant · cites it directly · 33 of its ownK063277 MapmateEp Medsystems, Inc. · 2006
Descendant · 2 generations on · 32 of its ownK092810 EP-Workmate System, Version 4.2St Jude Medical · 2009
Descendant · 3 generations on · 31 of its ownK132073 EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

1998high 9 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 57 · See all

K992968Carto EP Navigation SystemBiosense Webster, Inc. · 1999 · cites it directly36descendants
K993729Modification to Carto EP Navigation SystemBiosense Webster, Inc. · 1999 · 2 generations on34descendants
K063277MapmateEp Medsystems, Inc. · 2006 · cites it directly33descendants
K092810EP-Workmate System, Version 4.2St Jude Medical · 2009 · 2 generations on32descendants
K132073EP-Workmate, EP-Nursemate, EP-Nursemate with Physio ModuleSt Jude Medical · 2013 · 3 generations on31descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954395	Carto System	Biosense, Ltd.	1995	—
+1	K992968	Carto EP Navigation System	Biosense Webster, Inc.	1999	—
+2	K993729	Modification to Carto EP Navigation System	Biosense Webster, Inc.	1999	—
+1	K063277	Mapmate	Ep Medsystems, Inc.	2006	—
+2	K092810	EP-Workmate System, Version 4.2	St Jude Medical	2009	—
+3	K132073	EP-Workmate, EP-Nursemate, EP-Nursemate with Physio Module	St Jude Medical	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2000	1	0
2002	2	0
2006	1	0
2007	1	0
2009	2	0
2010	1	0
2013	3	0
2014	1	0
2015	2	0
2016	2	0
2017	1	0
2018	4	0
2019	1	0
2020	3	0
2021	3	0
2022	3	0
2023	4	0
2024	3	0
2025	9	0
2026	7	0

FIG. 1 — Lineage of K954395, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in DQK? 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

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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? (57)

See all 57

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

Number	Device	Applicant	Decided	Descendants
K992968	Carto EP Navigation System	Biosense Webster, Inc.	1999	36
K063277	Mapmate	Ep Medsystems, Inc.	2006	33
K993414	Prucka Engineering Inc. Cardiolab EP System,Version 4.2	Prucka Engineering, Inc.	2000	18
K961903	Magellan	Biosense, Ltd.	1998	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?

Of its descendants, K992968 (Biosense Webster, Inc., 1999) has gone furthest, with 36 descendants of its own.

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	—

https://510kreport.com/device/K954395 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954395: Carto System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954395

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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