510(k) · Cleared
ClearedCronus Guidewire, Model 001-001470-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stereotaxis, Inc. · NDQ System, Catheter Or Guidewire, Steerable (Magnetic)
Cleared on Dec 9, 2005 as substantially equivalent to K013484 (Stereotaxis, Inc., 2002) and 3 other predicates after a 197-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Dec 9, 2005
- Review
- 197 days
- Class
- Class II
- Product code
- NDQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K941895 (1994). 22 ancestors in all, the oldest K900765 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK941895 Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic CoatingScimed Life Systems, Inc. · 1994
- 3 generations backK970244 Scimed Choice Family of Ptca Guide WiresScimed Life Systems, Inc. · 1997
- 2 generations backK021363 Endovascular Guide WireStereotaxis, Inc. · 2002 · Recalled
- 1 generation backK042854 Stereotaxis Endovascular Guide WireStereotaxis, Inc. · 2005
- This deviceK051373 Cronus Guidewire, Model 001-001470-1Stereotaxis, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K941895 | Scimed 0.014 Ptca Guide Wire with Ice Hydrophilic Coating | Scimed Life Systems, Inc. | 1994 | — |
| −3 | K970244 | Scimed Choice Family of Ptca Guide Wires | Scimed Life Systems, Inc. | 1997 | — |
| −2 | K021363 | Endovascular Guide Wire | Stereotaxis, Inc. | 2002 | 6 |
| −1 | K042854 | Stereotaxis Endovascular Guide Wire | Stereotaxis, Inc. | 2005 | — |
| 0 (this device) | K051373 | Cronus Guidewire, Model 001-001470-1 | Stereotaxis, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 6 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 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 NDQ? 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013484 | Telstar Magnetic Navigation Systems [MNS}, Telstar BI-Plane Digital Imaging System…Summary page 5…orient the distal tip of a magnetically actuated guidewire. The Telstar® Digital Imaging System [TIS], previously cleared under K013484 and K022565, provides visualization through standard fluoroscopy. The Cronus® Modified is a conventional 0.… | 2002 |
| * | K983831 | VECTORVISION2Summary page 5…2 2 System [TMNS] (KO13484) and the BrainLAB VectorVision (VV ) (K983831) predicate devices. The Stereotaxis Cronus® Modified is substantially equivalent to the… | 1999 |
| * | K042854 | Stereotaxis Endovascular Guide WireSummary page 5…83831) predicate devices. The Stereotaxis Cronus® Modified is substantially equivalent to the Stereotaxis Cronus® Predicate (K042854) and the Boston Scientific TRANSEND TM EX Platinum Steerable Guide Wire (K971254) predicate… | 2005 |
| * | K971254 | Transend EX Platinum GuidewireSummary page 5…valent to the Stereotaxis Cronus® Predicate (K042854) and the Boston Scientific TRANSEND TM EX Platinum Steerable Guide Wire (K971254) predicate devices. Contact Kelly Rowland Regulatory Specialist D… | 1997 |
| † | K022565 | Telstar Biplane Digital Imaging System [Tis] Model 030-000915 | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 3 of the 22 ancestors have a recall of any class.
- 4 other devices also cite its predicate K013484.
How does its category compare?
All NDQ devicesNDQ 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
MAUDE reports naming product code NDQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Stereotaxis Cronus™ Endovascular Guidewire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the neurovasculature, coronary and peripheral vasculature during PTCA or other intravascular interventional procedures. The Stereotaxis Cronus™ Endovascular Guidewire is not intended for use without a Stereotaxis Magnetic Navigation System [MNS]. Rotational atherectomy devices and any…
Read the full statement (100 words)
The Stereotaxis Cronus™ Endovascular Guidewire is intended to introduce and position over-the-wire catheters and other over-the-wire therapeutic devices within the neurovasculature, coronary and peripheral vasculature during PTCA or other intravascular interventional procedures.
The Stereotaxis Cronus™ Endovascular Guidewire is not intended for use without a Stereotaxis Magnetic Navigation System [MNS]. Rotational atherectomy devices and any ferromagnetic interventional devices are contraindicated for use with the Stereotaxis Endovascular Guidewire.
The TMNS is intended to navigate a magnet-tipped device through tissue to designated target sites in the right and left heart, coronary, peripheral, and neurovasculature by orienting the device tip in a desired direction.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051373 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051373: Cronus Guidewire, Model 001-001470-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051373
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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