510(k) · Cleared
Recalled · Class II · 2025Zenition 50
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 Dec 31, 2018 as substantially equivalent to K010435 (Philips Medical Systems, Inc., 2001) after a 54-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 6 times.
- Decided
- Dec 31, 2018
- Review
- 54 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010435 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010435 Philips BV Pulsera/EnduraPhilips Medical Systems, Inc. · 2001 · Recalled
- This deviceK183101 Zenition 50Philips Medical Systems Nederland B.V. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010435 | Philips BV Pulsera/Endura | Philips Medical Systems, Inc. | 2001 | 12 |
| 0 (this device) | K183101 | Zenition 50 | Philips Medical Systems Nederland B.V. | 2018 | — |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2025 | Class II | Z-0241-2026 | Process control | Over time some systems may experience loss of imaging functionality and/or poor image quality due to potential corrosion of the Image Intensifier Television (IITV) control board. |
| Feb 25, 2025 | Class II | Z-1580-2025 | 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-0352-2025 | 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. |
| Dec 2, 2021 | Class II | Z-0647-2022 | Under Investigation by firm | Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot… |
| Apr 10, 2020 | Class II | Z-1932-2020 | Device Design | When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V)… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K010435.
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. 2018, 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 Zenition 50 device 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 Zenition 50 device 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 as stated in the FDA summary.
https://510kreport.com/device/K183101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183101: Zenition 50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183101
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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