510(k) · Cleared
ClearedAltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical System Nederland B.V. · DQK Computer, Diagnostic, Programmable
Cleared on Dec 17, 2020 as substantially equivalent to K162643 (St Jude Medical, 2016) and 2 other predicates after a 239-day review. Its family tree reaches back 5 generations to 1992. 3 later devices descend from it.
- Decided
- Dec 17, 2020
- Review
- 239 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K921310 (1992). 13 ancestors in all, the oldest K863137 (1986). 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
- 4 generations backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
- 3 generations backK992051 Radifocus OptitorqueTerumo Medical Corp. · 1999
- 2 generations backK082736 Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008
- 1 generation backK150232 Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp. · 2015
- This deviceK201081 AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V. · 2020
- Descendant · cites it directly · 2 of its ownK223918 AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V. · 2023
- Descendant · 2 generations on · 1 of its ownK233853 LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. · 2024
- Descendant · 3 generations on · 0 of its ownK252645 LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. · 2025
Most influential descendants
Showing 3 of 3 · See all- K223918AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V. · 2023 · cites it directly2descendants
- K233853LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. · 2024 · 2 generations on1descendant
- K252645LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921310 | Cordis 6 French Paragon Angiographic Catheter | Cordis Corp. | 1992 | — |
| −4 | K960975 | 1-4F Infiniti Angiographic Catheter | Cordis Corp. | 1996 | 1 |
| −3 | K992051 | Radifocus Optitorque | Terumo Medical Corp. | 1999 | — |
| −2 | K082736 | Radifocus Optitorque Angiographic Catheter | Terumo Medical Corp. | 2008 | — |
| −1 | K150232 | Radifocus Optitorque Angiographic Catheter | Ashitaka Factory of Terumo Corp. | 2015 | — |
| 0 (this device) | K201081 | AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter | Philips Medical System Nederland B.V. | 2020 | — |
| +1 | K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub | Philips Medical Systems Nederland B.V. | 2023 | — |
| +2 | K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2024 | — |
| +3 | K252645 | LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K162643 | MediGuide Technology SystemSummary page 4…ter, 21 CFR 870.1200: Class II Product code DQO PREDICATE DEVICES AltaTrack equipment MediGuide™ Technology System Version 17.0 (K162643) AltaTrack Guidewire Radifocus Glidewire® (K152740) AltaTrack Catheter Radifocus® Optitorque™ Angiographic Cathe… | 2016 |
| * | K152740 | Radifocus GlidewireSummary page 4…Product code DQO PREDICATE DEVICES AltaTrack equipment MediGuide™ Technology System Version 17.0 (K162643) AltaTrack Guidewire Radifocus Glidewire® (K152740) AltaTrack Catheter Radifocus® Optitorque™ Angiographic Catheter (K150232) DEVICE DESCRIPTION AltaTrack equipment… | 2015 |
| * | K150232 | Radifocus Optitorque Angiographic CatheterSummary page 4…nology System Version 17.0 (K162643) AltaTrack Guidewire Radifocus Glidewire® (K152740) AltaTrack Catheter Radifocus® Optitorque™ Angiographic Catheter (K150232) DEVICE DESCRIPTION AltaTrack equipment The AltaTrack equipment is a visualization device with Fiber Optic… | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub | 2023 | 2 |
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 28 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K223918 (Philips Medical Systems Nederland B.V., 2023) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K162643.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The AltaTrack equipment is an imaging device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected AltaTrack Catheter and/or AltaTrack Guidewire during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of an AltaTrack Catheter and/or AltaTrack Guidewire. The AltaTrack Guidewire is an angiographic guidewire with Fiber Optic…
Read the full statement (121 words)
The AltaTrack equipment is an imaging device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected AltaTrack Catheter and/or AltaTrack Guidewire during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real time of an AltaTrack Catheter and/or AltaTrack Guidewire.
The AltaTrack Guidewire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter during navigation in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
The AltaTrack Catheter is an angiographic catheter with Fiber Optic RealShape (FORS) technology, intended to deliver radiopaque media or lead a guidewire in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
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/K201081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201081: AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201081
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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