510(k) · Cleared
ClearedZenition 30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Aug 7, 2026 as substantially equivalent to K232420 (Philips Medical Systems Nederland B.V., 2024) after a 221-day review. Its family tree reaches back 8 generations to 2004.
- Decided
- Aug 7, 2026
- Review
- 221 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K042646 (2004). No later device cites it as a predicate yet.
- Root · 8 generations backK042646 DynactSiemens Medical Systems, Inc. · 2004
- 7 generations backK061685 PulseraPhilips Medical Systems North America Co. · 2006
- 6 generations backK090590 Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
- 5 generations backK133819 VeradiusPhilips Medical Systems Nederland B.V. · 2014
- 4 generations backK142708 Veradius UnityPhilips Medical Systems Nethrlands BV · 2014 · Recalled
- 3 generations backK183040 Zenition 70Philips Medical Systems Nederland B.V. · 2018 · Recalled
- 2 generations backK212813 Zenition 70Philips Medical Systems Nederland B.V. · 2021 · Recalled
- 1 generation backK232420 Zenition 30Philips Medical Systems Nederland B.V. · 2024
- This deviceK254205 Zenition 30Philips Medical Systems Nederland B.V. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K042646 | Dynact | Siemens Medical Systems, Inc. | 2004 | — |
| −7 | K061685 | Pulsera | Philips Medical Systems North America Co. | 2006 | — |
| −6 | K090590 | Veradius, Model 718-130 | Philips Medical Systems North America Co. | 2009 | — |
| −5 | K133819 | Veradius | Philips Medical Systems Nederland B.V. | 2014 | — |
| −4 | K142708 | Veradius Unity | Philips Medical Systems Nethrlands BV | 2014 | 4 |
| −3 | K183040 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2018 | 5 |
| −2 | K212813 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2021 | 4 |
| −1 | K232420 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2024 | — |
| 0 (this device) | K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2026 | — |
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 18.2 · 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.
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 22 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 8 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. 2026, 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 device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
Applications:
* Orthopedic
* Neuro
» Abdominal
» Vascular
* Thoracic
*» Cardiac
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/K254205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254205: Zenition 30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254205
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026