510(k) · Cleared
ClearedCarto EP Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on May 5, 2000 after a 99-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 114 devices in its family, counting itself, have a Class I recall. 113 later devices descend from it.
- Decided
- May 5, 2000
- Review
- 99 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
113 later devices descend from it, 2 citing it directly. 5 of the 114 devices in this family, counting this one, have a Class I recall.
- This deviceK000248 Carto EP Navigation SystemBiosense Webster, Inc. · 2000
- Descendant · cites it directly · 112 of its ownK013083 Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001
- Descendant · 2 generations on · 101 of its ownK020863 Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003
- Descendant · 3 generations on · 99 of its ownK042999 Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005
- Descendant · 4 generations on · 58 of its ownK070240 Carto XP EP Navigation System, Version 9Biosense Webster, Inc. · 2007
- Descendant · 2 generations on · 47 of its ownK072202 Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External…Biosense Webster, Inc. · 2007
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…7 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…8 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…8 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…8 generations on · 2023
Most influential descendants
Showing 5 of 113 · See all- K013083Carto XP EP Navigation SystemBiosense Webster, Inc. · 2001 · cites it directly112descendants
- K020863Carto XP and Qwikmap EP Navigation SystemBiosense Webster, Inc. · 2003 · 2 generations on101descendants
- K042999Carto XP EP Navigation System, Software Verison 8Biosense Webster, Inc. · 2005 · 3 generations on99descendants
- K070240Carto XP EP Navigation System, Version 9Biosense Webster, Inc. · 2007 · 4 generations on58descendants
- K072202Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference Patches…Biosense Webster, Inc. · 2007 · 2 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000248 | Carto EP Navigation System | Biosense Webster, Inc. | 2000 | — |
| +1 | K013083 | Carto XP EP Navigation System | Biosense Webster, Inc. | 2001 | — |
| +2 | K020863 | Carto XP and Qwikmap EP Navigation System | Biosense Webster, Inc. | 2003 | — |
| +3 | K042999 | Carto XP EP Navigation System, Software Verison 8 | Biosense Webster, Inc. | 2005 | — |
| +4 | K070240 | Carto XP EP Navigation System, Version 9 | Biosense Webster, Inc. | 2007 | — |
| +2 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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 |
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.
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 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (113)
See all 1132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 7 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 · 8 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 · 8 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 · 8 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K013083 (Biosense Webster, Inc., 2001) has gone furthest, with 112 descendants of its own.
How does its category compare?
All DQK devicesDQK 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 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/K000248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000248: Carto EP Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000248
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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