510(k) · Cleared
ClearedPari-Path Surgical Navigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paritic, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Jun 27, 2014 as substantially equivalent to K053610 (Traxtal Technologies, Inc., 2006) and 2 other predicates after a 189-day review. Its family tree reaches back 8 generations to 1994. 6 of the 68 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 27, 2014
- Review
- 189 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K911783 (1994). 67 ancestors in all, the oldest K844472 (1985). No later device cites it as a predicate yet. 6 of the 68 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 7 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 6 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 5 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 4 generations backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- 3 generations backK080624 Navstationirad Emt, Version 1.1Cas Innovations AG · 2008
- 2 generations backK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
- 1 generation backK111818 Sonixgps Needle SensorUltrasonix Medical Corporation · 2012
- This deviceK133901 Pari-Path Surgical Navigation SystemParitic, Inc. · 2014
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −7 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −6 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −5 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −4 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| −3 | K080624 | Navstationirad Emt, Version 1.1 | Cas Innovations AG | 2008 | — |
| −2 | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax… | Civco | 2009 | 17 |
| −1 | K111818 | Sonixgps Needle Sensor | Ultrasonix Medical Corporation | 2012 | — |
| 0 (this device) | K133901 | Pari-Path Surgical Navigation System | Paritic, Inc. | 2014 | — |
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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K093046 | FDA’s K093046 is Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX (5 Models, Different Sizes Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2011 |
| * | K053610 | AbarisSummary page 3…stem surgery _________________system 510(k) K123720 K093l)46 K053610 Klll1818 K092619 Number Manufacture Paritic Inc Veran Traxtal Ultrasonix… | 2006 |
| * | K111818 | Sonixgps Needle SensorSummary page 7…simulated instrument with respect to images of the target organs of a patient on a computer monitor screen. * Like the predicate devices: SonixOPS Needle Sensor (K 111818) and ABARIS Computer assisted, image-guided surgery system (K0536 10), the new subject d evice. Pani-path surgical navi… | 2012 |
| * | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal…Summary page 3…surgery _________________system 510(k) K123720 K093l)46 K053610 Klll1818 K092619 Number Manufacture Paritic Inc Veran Traxtal Ultrasonix CIVCO… | 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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 2 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 20 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 22 of the 67 ancestors have a recall of any class; 6 have a Class I recall.
- 6 other devices also cite its predicate K053610.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
The pani-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound imaging systems. It displays the simulated image of an interventions[ instrument ( a tracked insertion tool), such as a biopsy needle,an ablation needle ,or probe,on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is…
Read the full statement (121 words)
The pani-path surgical navigation system is a stereotactic accessory for Computed Tomography(CT) and Ultrasound imaging systems.
It displays the simulated image of an interventions[ instrument ( a tracked insertion tool), such as a biopsy needle,an ablation needle ,or probe,on a computer monitor screen that shows an image model of the target organs and the current and the projected future path of the interventional instrument. Ultrasound imaging is incorporated with the pani-path surgical navigation system for the situation in which the target organs may move because of patients's respiratory.
It is intended for treatment planning and intra-operative guidance for surgical procedures. It is intended for use in clinical interventionals and for anatomical structures where imaging is currently used for visualizing such procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133901 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133901: Pari-Path Surgical Navigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133901
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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