510(k) · Cleared
Recalled · Class II · 2023Philips BV Pulsera/Endura
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Mar 12, 2001 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 91 devices in its family, counting itself, has a Class I recall. 90 later devices descend from it. It has been recalled 12 times.
- Decided
- Mar 12, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 12
- Predicates
- 0
90 later devices descend from it, 3 citing it directly. 1 of the 91 devices in this family, counting this one, has a Class I recall.
- This deviceK010435 Philips BV Pulsera/EnduraPhilips Medical Systems, Inc. · 2001
- Descendant · cites it directly · 83 of its ownK032280 Siremobil Iso-C 3DSiemens AG · 2003
- Descendant · 2 generations on · 52 of its ownK050996 O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · Recalled
- Descendant · 3 generations on · 51 of its ownK060344 O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · Recalled
- Descendant · 2 generations on · 33 of its ownK081672 C-InsightMazor Surgical Technologies, Ltd. · 2008
- Descendant · 3 generations on · 31 of its ownK102130 Tenzing SystemMazor Surgical Technologies, Ltd. · 2010
Showing 5 of 90 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 90 · See all- K032280Siremobil Iso-C 3DSiemens AG · 2003 · cites it directly83descendants
- K050996O-Arm Imaging SystemBreakaway Imaging, LLC · 2005 · 2 generations on52descendants
- K060344O-Arm Imaging SystemBreakaway Imaging, LLC · 2006 · 3 generations on51descendants
- K081672C-InsightMazor Surgical Technologies, Ltd. · 2008 · 2 generations on33descendants
- K102130Tenzing SystemMazor Surgical Technologies, Ltd. · 2010 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010435 | Philips BV Pulsera/Endura | Philips Medical Systems, Inc. | 2001 | — |
| +1 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| +2 | K050996 | O-Arm Imaging System | Breakaway Imaging, LLC | 2005 | 4 |
| +3 | K060344 | O-Arm Imaging System | Breakaway Imaging, LLC | 2006 | 1 |
| +2 | K081672 | C-Insight | Mazor Surgical Technologies, Ltd. | 2008 | — |
| +3 | K102130 | Tenzing System | Mazor Surgical Technologies, Ltd. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 6 | 1 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 9 | 0 |
| 2025 | 12 | 0 |
| 2026 | 12 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (90)
See all 903 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 4, 2023 | Class II | Z-0224-2024 | 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. |
| Nov 12, 2021 | Class II | Z-0355-2022 | Device Design | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns |
| Nov 12, 2021 | Class II | Z-0356-2022 | Device Design | Instructions for Use do not specify the maximum surface temperature of the X-ray tank (assembly housing the X-ray tube, beam filter & cooling oil) and the image intensifier/detector of the system as required an result in burns |
| Oct 4, 2011 | Not classified | Z-0118-2012 | Nonconforming Material/Component | Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt |
| Oct 4, 2011 | Not classified | Z-0116-2012 | Nonconforming Material/Component | Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt |
| Oct 4, 2011 | Not classified | Z-0117-2012 | Nonconforming Material/Component | Front plate broke in to two pieces causing the C-Arm to suspend on the single central bolt |
| Dec 14, 2010 | Not classified | Z-1604-2011 | Device Design | The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems. |
| Dec 14, 2010 | Not classified | Z-1605-2011 | Device Design | The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems. |
| Sep 10, 2008 | Not classified | Z-2463-2010 | Other | The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. Unwanted C-arm movement… |
| Sep 10, 2008 | Not classified | Z-2464-2010 | Other | The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. Unwanted C-arm movement… |
| Sep 5, 2008 | Not classified | Z-0140-2011 | Component design/selection | Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor |
| Sep 5, 2008 | Not classified | Z-0141-2011 | Component design/selection | Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor |
The 5 latest of 12 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K032280 (Siemens AG, 2003) has gone furthest, with 83 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.
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 | — |
https://510kreport.com/device/K010435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010435: Philips BV Pulsera/Endura.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010435
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026