510(k) · Cleared
Recalled · Class II · 2023Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath Always-on Tip Tracked Aspiration Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Veran Medical Technologies, Inc. · JAK System, X-Ray, Tomography, Computed
Cleared on Dec 21, 2012 as substantially equivalent to K091934 (Veran Medical Technologies, Inc., 2009) after a 157-day review. Its family tree reaches back 11 generations to 1993. 1 of the 23 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 13 times.
- Decided
- Dec 21, 2012
- Review
- 157 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 13
- Predicates
- 1
Its longest line of descent runs back 11 generations to K926514 (1993). 21 ancestors in all, the oldest K882061 (1988). 1 later device descends from it, 1 citing it directly. 1 of the 23 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 7 generations between
- 3 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK091934 IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory…Veran Medical Technologies, Inc. · 2009
- This deviceK122106 Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip…Veran Medical Technologies, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK170023 SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc. · 2017 · Recalled
Show all 11 generations
- Root · 11 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 10 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 9 generations backK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- 8 generations backK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- 7 generations backK052260 Superdimension/Bronchus 4.1Superdimension, Ltd. · 2005 · Recalled
- 6 generations backK052852 Superdimension/Bronchus PremiumSuperdimension, Ltd. · 2005 · Recalled
- 5 generations backK062315 Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2006 · Recalled
- 4 generations backK071473 Modification to Superdimension/Bronchus Premium 2Superdimension, Ltd. · 2007
- 3 generations backK080271 Inreach SystemSuperdimension, Ltd. · 2008
- 2 generations backK081379 Modification to Inreach SystemSuperdimension, Ltd. · 2008
- 1 generation backK091934 IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory…Veran Medical Technologies, Inc. · 2009
- This deviceK122106 Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip…Veran Medical Technologies, Inc. · 2012
Class I recalls in this family
- K023984 Modification to Olympus Bronchoscopes BF-40…9 generations back · 2003
Most influential descendants
Showing 1 of 1 · See all- K170023SPiN Thoracic Navigation SystemVeran Medical Technologies, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −10 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −9 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| −8 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| −7 | K052260 | Superdimension/Bronchus 4.1 | Superdimension, Ltd. | 2005 | 2 |
| −6 | K052852 | Superdimension/Bronchus Premium | Superdimension, Ltd. | 2005 | 1 |
| −5 | K062315 | Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2006 | 1 |
| −4 | K071473 | Modification to Superdimension/Bronchus Premium 2 | Superdimension, Ltd. | 2007 | — |
| −3 | K080271 | Inreach System | Superdimension, Ltd. | 2008 | — |
| −2 | K081379 | Modification to Inreach System | Superdimension, Ltd. | 2008 | — |
| −1 | K091934 | IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4… | Veran Medical Technologies, Inc. | 2009 | — |
| 0 (this device) | K122106 | Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked… | Veran Medical Technologies, Inc. | 2012 | — |
| +1 | K170023 | SPiN Thoracic Navigation System | Veran Medical Technologies, Inc. | 2017 | 15 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K091934 | IG4 Endobronchial, Model Sys-0200, Navigation Guidewire (Accessory to IG4…Summary page 1…ereotactic accessory Classification Name: Computed Tomography X-ray System Classification Code: JAK Equivalent Legally-Marketed Device: ig4 M Endlobronchial (K091934) Device Description: The SPiN Drive® is an accessory for a CT system that utilizes electromagnetic tracking technology to locate… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170023 | SPiN Thoracic Navigation System | 2017 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2023 | Class II | Z-2663-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2661-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2659-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2662-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| Aug 10, 2023 | Class II | Z-2664-2023 | Under Investigation by firm | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to… |
| May 15, 2023 | Class II | Z-2263-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2269-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2267-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2268-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2266-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2264-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2265-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
| May 15, 2023 | Class II | Z-2262-2023 | Component design/selection | Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay |
The 5 latest of 13 recalls; the web page lists all.
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.
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 9 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 9 of the 21 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170023 (Veran Medical Technologies, Inc., 2017) has gone furthest, with 0 descendants of its own.
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. 2012, 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 ig4 Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying: " An interventional instrument such as abiopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s). " Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in…
Read the full statement (109 words)
The ig4 Image Guided System is a stereotactic accessory for Computed Tomography (CT) and endoscopic bronchoscope systems. The ig4 System is indicated for displaying:
" An interventional instrument such as abiopsy needle, an aspiration needle, or ablation needle on a computer monitor that also displays a CT-based model of the target organ(s).
" Images of the tracheobronchial tree to aid a physician in guiding endoscopic tools, catheters or guidewires, in the pulmonary tract.
The ig4 System compensates for the patient's respiratory phases.
The ig4TM System is intended for use in clinical interventions and for anatomical structures where computed tomography and/or endoscopic bronchoscopy are currently used for visualizing such procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122106 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122106: Spin Drive Always-on Tip Tracked Steerable Catheter Always-on Tip Tracked Sheath Always-on Tip Tracked Aspiration Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122106
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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