510(k) · Cleared
Clearedomni TRAX Active Patient Tracker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Civco Medical Instruments CO Inc Dba Civco Medical Solutions · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jan 23, 2015 as substantially equivalent to K092619 (Civco, 2009) after a 58-day review. Its family tree reaches back 7 generations to 1994. 6 of the 67 devices in its family, counting itself, have a Class I recall.
- Decided
- Jan 23, 2015
- Review
- 58 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K911783 (1994). 66 ancestors in all, the oldest K844472 (1985). No later device cites it as a predicate yet. 6 of the 67 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 6 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 5 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 4 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 3 generations backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- 2 generations backK080624 Navstationirad Emt, Version 1.1Cas Innovations AG · 2008
- 1 generation backK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
- This deviceK143396 omni TRAX Active Patient TrackerCivco Medical Instruments CO Inc Dba Civco Medical Solutions · 2015
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −6 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −5 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −4 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −3 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| −2 | K080624 | Navstationirad Emt, Version 1.1 | Cas Innovations AG | 2008 | — |
| −1 | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax… | Civco | 2009 | 17 |
| 0 (this device) | K143396 | omni TRAX Active Patient Tracker | Civco Medical Instruments CO Inc Dba Civco Medical Solutions | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 1 |
| 1997 | 3 | 0 |
| 1998 | 7 | 1 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 1 |
| 2005 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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.
6 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Summary page 4…YO, LNH B. Predicate Device The proposed device is substantially equivalent to the following predicate device: Predicate Device Manufacturer Active Fiducial Marker in K092619 Electromagnetic Tracking CIVCO Medical System Instruments Co., Inc. The purpose of this 510(k) is to expand the indications for… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (6 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.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 2 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 22 of the 66 ancestors have a recall of any class; 6 have a Class I recall.
- 5 other devices also cite its predicate K092619.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The device is intended to provide physicians with a tool for electromagnetic (EM) tracking of instruments with respect to pre-acquired or real-time data. The device is intended for use in Magnetic Resonance Imaging (MRI) and ultrasound (US) environments.
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/K143396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143396: omni TRAX Active Patient Tracker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143396
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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