510(k) Report

510(k) · Cleared

Cleared

Niobe Magnetic Navigation System W/Navigant Workstation

K060967510(k) TraditionalCleared Oct 19, 2006195-day reviewClass II21 CFR 870.1290

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

Stereotaxis, Inc. · NDQ System, Catheter Or Guidewire, Steerable (Magnetic)

Cleared on Oct 19, 2006 after a 195-day review. The FDA summary names its predicate without a number. 5 of the 57 devices in its family, counting itself, have a Class I recall. 56 later devices descend from it.

Decided
Oct 19, 2006
Review
195 days
Class
Class II
Product code
NDQ
Recalls
None
Predicates
0

56 later devices descend from it, 4 citing it directly. 5 of the 57 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2009: 1 descendant cleared2019: 5 descendants cleared, 1 with a Class I recall12012: 4 descendants cleared2016: 3 descendants cleared2014: 4 descendants cleared2015: 1 descendant cleared2017: 2 descendants cleared2018: 8 descendants cleared2023: 4 descendants cleared, 1 with a Class I recall12020: 3 descendants cleared2024: 6 descendants cleared, 2 with a Class I recall22022: 3 descendants cleared2025: 4 descendants cleared, 1 with a Class I recall12026: 7 descendants cleared2021: 1 descendant cleared20052010201520202025
  1. This deviceK060967 Niobe Magnetic Navigation System W/Navigant WorkstationStereotaxis, Inc. · 2006
  2. Descendant · cites it directly · 31 of its ownK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
  3. Descendant · 2 generations on · 27 of its ownK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · Recalled
  4. Descendant · 3 generations on · 20 of its ownK170600 CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017
  5. Descendant · 4 generations on · 19 of its ownK180238 CARTO 3 EP Navigation System, Version 6.0 and Accessories with…Biosense Webster, Inc. · 2018
  6. Descendant · 5 generations on · 16 of its ownK191660 CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · Recalled

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2009: 12012: 42014: 42015: 12016: 32017: 22018: 82019: 52020: 32021: 12022: 32023: 42024: 62025: 42026: 7
2009high 8 (2018) · low 0 (2010)2026

Class I recalls in this family

  • K190106 Intra-Operative Positioning System; Simple Curve…3 generations on · 2019
  • K242133 Intra-Operative Positioning System (IOPS®)…4 generations on · 2024
  • K241243 Intra-Operative Positioning System (IOPS®)…4 generations on · 2024
  • K230309 Intra-Operative Positioning System (IOPS®)…4 generations on · 2023

Most influential descendants

Showing 5 of 56 · See all
  • K120550Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc. · 2012 · cites it directly31descendants
  • K133916Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · 2 generations on27descendants
  • K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017 · 3 generations on20descendants
  • K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTBiosense Webster, Inc. · 2018 · 4 generations on19descendants
  • K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc. · 2019 · 5 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060967Niobe Magnetic Navigation System W/Navigant WorkstationStereotaxis, Inc.2006—
+1K120550Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc.20122
+2K133916Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc.20142
+3K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc.2017—
+4K180238CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINTBiosense Webster, Inc.2018—
+5K191660CARTO 3 EP Navigation System, Version 7.1 and AccessoriesBiosense Webster, Inc.20191

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201240
201440
201510
201630
201720
201880
201951
202030
202110
202230
202341
202462
202541
202670
FIG. 1 — Lineage of K060967, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*—Stereotaxis Guidewire
Named without a submission number
—
*—Stereotaxis Telstar® Magnetic Navigation System [MNS]
Named without a submission number
—
*—Navigant TM Navigation Workstation [2.1] [NWS2]
Named without a submission number
—
*—Stereotaxis Niobe® Magnetic Navigation System
Named without a submission number
—

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K120550Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc.201231
K091781Guided Medical Positioning System (GMPS)Mediguide, Ltd.200911
K120834Corpath 200 SystemCorindus, Inc.20128
K183027Steerable catheter control systemStereotaxis, Inc.20192

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 · 3 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 · 4 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 · 4 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 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
  • K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 4 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K120550 (Biosense Webster, Inc., 2012) has gone furthest, with 31 descendants of its own.

How does its category compare?

All NDQ devices

NDQ System, Catheter Or Guidewire, Steerable (Magnetic): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NDQ

FDA has decided no NDQ device since 2007.

Median 510(k) review, days · NDQ

Too few NDQ 510(k)s in any year since 2007 to give a median.

Recalls per year · NDQ

No recall names NDQ since 2007.

Adverse event reports per year · NDQ

1in 2022

2009: 12011: 12014: 12019: 12020: 42022: 1
2007high 4 (2020) · low 0 (2007)2025

MAUDE reports naming product code NDQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—01
20100—00
20110—01
20120—00
20130—00
20140—01
20150—00
20160—00
20170—00
20180—00
20190—01
20200—04
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Niobe® MNS with NavigantTM NWS is intended to navigate compatible magnetic devices through tissue to designated target sites in the right and left heart, coronary vasculature, neurovasculature and peripheral vasculature by orienting the device tip in a desired direction.

Indications for use as stated in the FDA summary.

More from Stereotaxis, Inc.

32 FDA decisions under this applicant name. See the company

  • K262744GenesisX RMNStereotaxis, Inc. · 2026
  • P240014/S001MAGiC Ablation CatheterStereotaxis, Inc. · 2026
  • K253473SynchronyStereotaxis, Inc. · 2026
  • P240014MAGiC Ablation CatheterStereotaxis, Inc. · 2026
  • K251792Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS)Stereotaxis, Inc. · 2025

Recent decisions in NDQ

The NDQ category page

  • K051373Cronus Guidewire, Model 001-001470-1Stereotaxis, Inc. · 2005

https://510kreport.com/device/K060967 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060967: Niobe Magnetic Navigation System W/Navigant Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060967

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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