510(k) · Cleared
ClearedCydar EV (Series B) and Cydar EV Maps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cydar, Ltd. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 3, 2021 as substantially equivalent to K160088 (Cydar, Ltd., 2016) and 1 other predicate after a 121-day review. Its family tree reaches back 8 generations to 1991. 1 later device descends from it.
- Decided
- Dec 3, 2021
- Review
- 121 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K913770 (1991). 27 ancestors in all, the oldest K852353 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 5 generations backK052995 Advantage Workstation 4.3.GE Healthcare · 2005 · Recalled
- 4 generations backK092639 Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT…GE Medical Systems SCS · 2009
- 3 generations backK121772 Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1Philips Medical Systems Nederland B.V. · 2013
- 2 generations backK151598 VesselNavigator Rel. 1.0Philips Medical Systems Nederland B.V. · 2015
- 1 generation backK160088 Cydar EVCydar, Ltd. · 2016
- This deviceK212442 Cydar EV (Series B) and Cydar EV MapsCydar, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK252500 CARA SystemCara Medical, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252500CARA SystemCara Medical, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −7 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −6 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −5 | K052995 | Advantage Workstation 4.3. | GE Healthcare | 2005 | 4 |
| −4 | K092639 | Innova Vision, Model S18751VN, Innova Trackvision, Model S18751VT, Innova… | GE Medical Systems SCS | 2009 | — |
| −3 | K121772 | Allura 3D-RA Rel 6, 3D Roadmap Rel 1, MR-CT Roadmap Rel 1 | Philips Medical Systems Nederland B.V. | 2013 | — |
| −2 | K151598 | VesselNavigator Rel. 1.0 | Philips Medical Systems Nederland B.V. | 2015 | — |
| −1 | K160088 | Cydar EV | Cydar, Ltd. | 2016 | — |
| 0 (this device) | K212442 | Cydar EV (Series B) and Cydar EV Maps | Cydar, Ltd. | 2021 | — |
| +1 | K252500 | CARA System | Cara Medical, Ltd. | 2026 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K160088 | Cydar EVSummary page 5…ared on 2021-11-03. S05.1.2 Device Name The device is know as Cydar EV. It is an an evolution of a previous device of the same name, which is the subject of 510(k) K160088. To distinguish the two devices, the older device is referred to as Cydar EV Series A, and the device that is the subject of thi… | 2016 |
| * | K141475 | EndosizeSummary page 6…Scope Cydar EV (primary predicate) Cydar Ltd K160088 CT import, intra-operative overlay, post-operative review Endosize Therenva SAS K141475 Measurements and segmentation on CT scans S05.1.4 Device Description Cydar EV is a Software-as-a-Service product and consist… | 2014 |
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 |
|---|---|---|---|
| K252500 | CARA System | 2026 | 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 30 years and passes through 6 companies; a new generation was cleared every 4.1 years on median.
- 6 of the 27 ancestors have a recall of any class.
- Of its descendants, K252500 (Cara Medical, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K160088.
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. 2021, 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?
Cydar EV provides tools to: * Import and visualise CT data * Segment and annotate vascular anatomy from CT data * Place and edit virtual guidewires and measure lengths on them * Make measurements of anatomical structures on planar sections of the CT data * Produce an operative plan from measurements and segmentation of preoperative vessel anatomy * Overlay planning information such as preoperative vessel anatomy onto live fluoroscopic images, aligned…
Read the full statement (274 words)
Cydar EV provides tools to:
* Import and visualise CT data
* Segment and annotate vascular anatomy from CT data
* Place and edit virtual guidewires and measure lengths on them
* Make measurements of anatomical structures on planar sections of the CT data
* Produce an operative plan from measurements and segmentation of preoperative vessel anatomy
* Overlay planning information such as preoperative vessel anatomy onto live fluoroscopic images, aligned based on the position of anatomical features present in both
* Non-rigidly transform the visualisation of anatomy when intra-operative vessel deformation is observed
* Post-operatively review data relating to procedures where the system was used
Cydar EV is intended to assist fluoroscopic X-ray guided endovascular procedures in the chest, abdomen, and pelvis by presenting the operative plan in the context of intraoperative fluoroscopy.
Cydar EV is intended to be used for patients undergoing a fluoroscopic X-ray guided endovascular surgery in the chest abdomen and pelvis, and who have had a pre-operative CT-scan.
The performance of the Cydar EV software in the presence of immature vertebral anatomy is unknown. The Instructions for Use explicitly state this uncertainty and that the software is therefore not recommended for use in patients under the age of 18.
IMPORTANT: Pre-Operative Maps show static anatomy derived from the pre-operative CT. Real-time anatomy moves with the cardiorespiratory cycle; progressive disease may cause the anatomy to change over time; and stiff wires, stents or other surgical instruments, may straighten and displace blood vessels from the pre-operative position
It is therefore mandatory to check the real-time anatomy with a suitable imaging technique, such as contrast angiography, before deploying any invasive medical device.
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/K212442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212442: Cydar EV (Series B) and Cydar EV Maps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212442
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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