510(k) · Cleared
ClearedEndoNaut
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therenva Sas · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 25, 2022 as substantially equivalent to K212383 (Therenva Sas, 2021) and 1 other predicate after a 103-day review. Its family tree reaches back 10 generations to 1991. 1 later device descends from it.
- Decided
- Oct 25, 2022
- Review
- 103 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K913770 (1991). 30 ancestors in all, the oldest K852353 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations between
- 3 generations backK160088 Cydar EVCydar, Ltd. · 2016
- 2 generations backK171829 EndoNautTherenva Sas · 2017
- 1 generation backK212383 EndoNautTherenva Sas · 2021
- This deviceK222070 EndoNautTherenva Sas · 2022
- Descendant · cites it directly · 0 of its ownK243432 Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG · 2025
Show all 10 generations
- Root · 10 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 9 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 8 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 7 generations backK052995 Advantage Workstation 4.3.GE Healthcare · 2005 · Recalled
- 6 generations backK092639 Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT…GE Medical Systems SCS · 2009
- 5 generations backK121772 Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V. · 2013
- 4 generations backK151598 VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V. · 2015
- 3 generations backK160088 Cydar EVCydar, Ltd. · 2016
- 2 generations backK171829 EndoNautTherenva Sas · 2017
- 1 generation backK212383 EndoNautTherenva Sas · 2021
- This deviceK222070 EndoNautTherenva Sas · 2022
Most influential descendants
Showing 1 of 1 · See all- K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADBrainlab AG · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −9 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −8 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −7 | K052995 | Advantage Workstation 4.3. | GE Healthcare | 2005 | 4 |
| −6 | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova… | GE Medical Systems SCS | 2009 | — |
| −5 | K121772 | Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1 | Philips Medical Systems Nederland B.V. | 2013 | — |
| −4 | K151598 | VesselNavigator Rel. 1.0 | Philips Medical Systems Nederland B.V. | 2015 | — |
| −3 | K160088 | Cydar EV | Cydar, Ltd. | 2016 | — |
| −2 | K171829 | EndoNaut | Therenva Sas | 2017 | — |
| −1 | K212383 | EndoNaut | Therenva Sas | 2021 | — |
| 0 (this device) | K222070 | EndoNaut | Therenva Sas | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K212383 | EndoNautSummary page 5…medical Manufacturer 510K number device name EndoNaut Therenva K212383 Predicate accessory Manufacturer 510K number name EndoNaut wo… | 2021 |
| * | K160376 | EndoSizeSummary page 5…red to in K212383 510(k) Model: TS1CA2DS1-2 submission EndoSize Therenva K160376 also referred to in K212383… | 2016 |
| * | — | EndoNaut workstation Named without a submission number |
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 |
|---|---|---|---|
| K243432 | Vascular Navigation PAD 2.0; Navigation Software Vascular PAD | 2025 | 0 |
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 31 years and passes through 7 companies; a new generation was cleared every 3.7 years on median.
- 6 of the 30 ancestors have a recall of any class.
- Of its descendants, K243432 (Brainlab AG, 2025) has gone furthest, with 0 descendants of its own.
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. 2022, 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?
EndoNaut is an image fusion software solution and computerized navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices. EndoNaut is indicated for use by Physicians for patients undergoing a fluoroscopy X-ray guided procedure in the chest, abdomen, pelvis, neck and lower limbs, such as aneurysm repair, artery/vein embolization, or peripheral artery disease treatment.…
Read the full statement (115 words)
EndoNaut is an image fusion software solution and computerized navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices.
EndoNaut is indicated for use by Physicians for patients undergoing a fluoroscopy X-ray guided procedure in the chest, abdomen, pelvis, neck and lower limbs, such as aneurysm repair, artery/vein embolization, or peripheral artery disease treatment.
The information provided by the software or system is in no way intended to substitute for, in whole or in part, the surgeon's judgment and analysis of the patient's condition.
It is mandatory to check the real-time anatomy with a suitable imaging technique, such as a contrast-enhanced angiography, before deploying any invasive medical device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222070: EndoNaut.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222070
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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