510(k) · Cleared
Recalled · Class II · 2025Zenition 70
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 Oct 1, 2021 as substantially equivalent to K183040 (Philips Medical Systems Nederland B.V., 2018) after a 28-day review. Its family tree reaches back 6 generations to 2004. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 1, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 6 generations to K042646 (2004). 3 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK042646 DynactSiemens Medical Systems, Inc. · 2004
- 5 generations backK061685 PulseraPhilips Medical Systems North America Co. · 2006
- 4 generations backK090590 Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
- 3 generations backK133819 VeradiusPhilips Medical Systems Nederland B.V. · 2014
- 2 generations backK142708 Veradius UnityPhilips Medical Systems Nethrlands BV · 2014 · Recalled
- 1 generation backK183040 Zenition 70Philips Medical Systems Nederland B.V. · 2018 · Recalled
- This deviceK212813 Zenition 70Philips Medical Systems Nederland B.V. · 2021
- Descendant · cites it directly · 1 of its ownK232420 Zenition 30Philips Medical Systems Nederland B.V. · 2024
- Descendant · 2 generations on · 0 of its ownK254205 Zenition 30Philips Medical Systems Nederland B.V. · 2026
- Descendant · cites it directly · 0 of its ownK240224 Zenition 90Philips Medical Systems Nederlands B.V. · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K042646 | Dynact | Siemens Medical Systems, Inc. | 2004 | — |
| −5 | K061685 | Pulsera | Philips Medical Systems North America Co. | 2006 | — |
| −4 | K090590 | Veradius, Model 718-130 | Philips Medical Systems North America Co. | 2009 | — |
| −3 | K133819 | Veradius | Philips Medical Systems Nederland B.V. | 2014 | — |
| −2 | K142708 | Veradius Unity | Philips Medical Systems Nethrlands BV | 2014 | 4 |
| −1 | K183040 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2018 | 5 |
| 0 (this device) | K212813 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2021 | — |
| +1 | K232420 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2024 | — |
| +2 | K254205 | Zenition 30 | Philips Medical Systems Nederland B.V. | 2026 | — |
| +1 | K240224 | Zenition 90 | Philips Medical Systems Nederlands B.V. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 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? (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? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 25, 2025 | Class II | Z-1581-2025 | Labeling design | A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation. |
| Oct 7, 2024 | Class II | Z-0353-2025 | Under Investigation by firm | Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure. |
| Oct 4, 2023 | Class II | Z-0226-2024 | Device Design | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion systems that have been delivered to Puerto Rico without a warning label and the Source-to-Skin Distance Spacer (Tube-spacer) is missing. |
| Jul 20, 2023 | Class II | Z-1583-2025 | Software design | Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K232420 (Philips Medical Systems Nederland B.V., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K183040.
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?
The proposed Zenition 70 is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the…
Read the full statement (112 words)
The proposed Zenition 70 is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.
The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. 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/K212813 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212813: Zenition 70.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212813
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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