510(k) · Cleared
ClearedCarto RMT EP Navigation System V8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Jun 19, 2006 after a 164-day review. The FDA summary names its predicate without a number. 49 later devices descend from it.
- Decided
- Jun 19, 2006
- Review
- 164 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 3 citing it directly.
- This deviceK060047 Carto RMT EP Navigation System V8Biosense 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 · cites it directly · 45 of its ownK090017 Carto 3 EP Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 34 of its ownK093455 Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 33 of its ownK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
- Descendant · 4 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
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 · cites it directly45descendants
- K093455Carto 3 Version 1.05 EP Navigation System and AccessoriesBiosense Webster, Inc. · 2009 · 2 generations on34descendants
- K103746Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation…Biosense Webster, Inc. · 2011 · 3 generations on33descendants
- K112007Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060047 | Carto RMT EP Navigation System V8 | Biosense Webster, Inc. | 2006 | — |
| +1 | K072202 | Carto 3 Navigation System (Model:FG-5400-00), Carto 3 External Reference… | Biosense Webster, Inc. | 2007 | — |
| +1 | K090017 | Carto 3 EP Navigation System, V1.0 and Accessories | Biosense Webster, Inc. | 2009 | 4 |
| +2 | K093455 | Carto 3 Version 1.05 EP Navigation System and Accessories | Biosense Webster, Inc. | 2009 | 1 |
| +3 | K103746 | Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3… | Biosense Webster, Inc. | 2011 | 1 |
| +4 | 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 |
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 13.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | — | CARTO™ XP EP Navigation System v8 Named without a submission number | |
| * | — | CARTO™ RMT EP Navigation System v7 Named without a submission number |
What descends from it? (49)
See all 493 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K072202 (Biosense Webster, Inc., 2007) has gone furthest, with 47 descendants of its own.
How does its category compare?
All DRF devicesDRF 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 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 intended use of the CARTO™ RMT EP Navigation System v8 is catheter-based atrial and ventricular mapping. The CARTO RMT System v8 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, impedance maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and…
Read the full statement (210 words)
The intended use of the CARTO™ RMT EP Navigation System v8 is catheter-based atrial and ventricular mapping.
The CARTO RMT System v8 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, impedance 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 CARTO RMT System v8 is intended to support EP procedures in the presence of the high metallic environment presented by the NIOBE I (PM3.0) and Niobe 2 (PM3.1 and PM3.2) Stereotaxis Magnetic Navigation Systems (MNS) in magnetic environments of up to 0.08 Tesla.
Although the CARTO™ RMT system requires the use of a magnetic steerable catheter, i.e. the NAVISTAR RMT, when used in conjunction with the Stereotaxis Niobe MNS, it also enables the use of the standard NAVISTAR and QWIKSTAR catheters when the Stereotaxis magnets are stowed away or when used in a conventional EP lab, maintaining full CARTO™ XP capabilities.
CARTO RMT System v8 includes 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/K060047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060047: Carto RMT EP Navigation System V8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060047
Report an extraction error
Are you the manufacturer?
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