510(k) · Cleared
ClearedVascular Navigation PAD 2.0; Navigation Software Vascular PAD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jul 22, 2025 as substantially equivalent to K222070 (Therenva Sas, 2022) after a 259-day review. Its family tree reaches back 11 generations to 1991.
- Decided
- Jul 22, 2025
- Review
- 259 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K913770 (1991). 31 ancestors in all, the oldest K852353 (1985). No later device cites it as a predicate yet.
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations between
- 3 generations backK171829 EndoNautTherenva Sas · 2017
- 2 generations backK212383 EndoNautTherenva Sas · 2021
- 1 generation backK222070 EndoNautTherenva Sas · 2022
- This deviceK243432 Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG · 2025
Show all 11 generations
- Root · 11 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 10 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 9 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 8 generations backK052995 Advantage Workstation 4.3.GE Healthcare · 2005 · Recalled
- 7 generations backK092639 Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT…GE Medical Systems SCS · 2009
- 6 generations backK121772 Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V. · 2013
- 5 generations backK151598 VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V. · 2015
- 4 generations backK160088 Cydar EVCydar, Ltd. · 2016
- 3 generations backK171829 EndoNautTherenva Sas · 2017
- 2 generations backK212383 EndoNautTherenva Sas · 2021
- 1 generation backK222070 EndoNautTherenva Sas · 2022
- This deviceK243432 Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −10 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −9 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −8 | K052995 | Advantage Workstation 4.3. | GE Healthcare | 2005 | 4 |
| −7 | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova… | GE Medical Systems SCS | 2009 | — |
| −6 | K121772 | Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1 | Philips Medical Systems Nederland B.V. | 2013 | — |
| −5 | K151598 | VesselNavigator Rel. 1.0 | Philips Medical Systems Nederland B.V. | 2015 | — |
| −4 | K160088 | Cydar EV | Cydar, Ltd. | 2016 | — |
| −3 | K171829 | EndoNaut | Therenva Sas | 2017 | — |
| −2 | K212383 | EndoNaut | Therenva Sas | 2021 | — |
| −1 | K222070 | EndoNaut | Therenva Sas | 2022 | — |
| 0 (this device) | K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | Brainlab AG | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1987 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 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 |
|---|---|---|---|
| * | K222070 | EndoNautSummary page 5…WB; LLZ Regulation Number 892.1650 Regulatory Class II Panel Radiology Predicate Device K222070 – EndoNaut Regulation Number: 21 CFR 892.1650; Classificati… | 2022 |
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 34 years and passes through 8 companies; a new generation was cleared every 3.3 years on median.
- 6 of the 31 ancestors have a recall of any class.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The software supports image guidance by overlaying vessel anatomy onto live fluoroscopic images in order to navigate guidewires, catheters, stents and other endovascular devices.
The device is indicated for use by physicians for patients undergoing endovascular PAD interventions of the lower limbs including iliac vessels.
The device is intended to be used in adults.
There is no other demographic, ethnic or cultural limitation for patients.
The information provided by the software or system is in no way intended to substitute for, in whole or in part, the physician’s judgment and analysis of the patient's condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243432: Vascular Navigation PAD 2.0; Navigation Software Vascular PAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243432
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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