510(k) · Cleared
ClearedLumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · DQK Computer, Diagnostic, Programmable
Cleared on Oct 24, 2025 as substantially equivalent to K233853 (Philips Medical Systems Nederland B.V., 2024) after a 64-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Oct 24, 2025
- Review
- 64 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921310 (1992). 16 ancestors in all, the oldest K863137 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK921310 Cordis 6 French Paragon Angiographic CatheterCordis Corp. · 1992
- 7 generations backK960975 1-4F Infiniti Angiographic CatheterCordis Corp. · 1996 · Recalled
- 6 generations backK992051 Radifocus OptitorqueTerumo Medical Corp. · 1999
- 5 generations backK082736 Radifocus Optitorque Angiographic CatheterTerumo Medical Corp. · 2008
- 4 generations backK150232 Radifocus Optitorque Angiographic CatheterAshitaka Factory of Terumo Corp. · 2015
- 3 generations backK201081 AltaTrack equipment, AltaTrack Guidewire, AltaTrack CatheterPhilips Medical System Nederland B.V. · 2020
- 2 generations backK223918 AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D HubPhilips Medical Systems Nederland B.V. · 2023
- 1 generation backK233853 LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. · 2024
- This deviceK252645 LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D HubPhilips Medical Systems Nederland B.V. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921310 | Cordis 6 French Paragon Angiographic Catheter | Cordis Corp. | 1992 | — |
| −7 | K960975 | 1-4F Infiniti Angiographic Catheter | Cordis Corp. | 1996 | 1 |
| −6 | K992051 | Radifocus Optitorque | Terumo Medical Corp. | 1999 | — |
| −5 | K082736 | Radifocus Optitorque Angiographic Catheter | Terumo Medical Corp. | 2008 | — |
| −4 | K150232 | Radifocus Optitorque Angiographic Catheter | Ashitaka Factory of Terumo Corp. | 2015 | — |
| −3 | K201081 | AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter | Philips Medical System Nederland B.V. | 2020 | — |
| −2 | K223918 | AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub | Philips Medical Systems Nederland B.V. | 2023 | — |
| −1 | K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub | Philips Medical Systems Nederland B.V. | 2024 | — |
| 0 (this device) | 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 |
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 26.7 · 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? (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 |
|---|---|---|---|
| * | K233853 | LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D HubSummary page 5…Part 870.1425 Device Class: II Product Code: DQK Predicate Devices: LumiGuide system (K233853), containing the following primary devices: Trade Name: LumiGuide Equipment R2.0… | 2024 |
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 33 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 1 of the 16 ancestors has a recall of any class.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub. The LumiGuide Wire is an…
Read the full statement (119 words)
The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.
The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.
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/K252645 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252645: LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252645
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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