510(k) · Cleared
ClearedC-beam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulmera, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on May 22, 2026 as substantially equivalent to K243303 (Ziehm Imaging GmbH, 2025) after a 267-day review. Its family tree reaches back 10 generations to 2000. 3 of the 18 devices in its family, counting itself, have a Class I recall.
- Decided
- May 22, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K003266 (2000). 17 ancestors in all. No later device cites it as a predicate yet. 3 of the 18 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 6 generations between
- 3 generations backK202360 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2020
- 2 generations backK231701 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2023 · Recalled
- 1 generation backK243303 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2025
- This deviceK252735 C-beamPulmera, Inc. · 2026
Show all 10 generations
- Root · 10 generations backK003266 Siremobil Iso-C 3DSiemens Medical Solutions USA, Inc. · 2000
- 9 generations backK032280 Siremobil Iso-C 3DSiemens AG · 2003
- 8 generations backK061310 Ziehm Vario 3D Digital Mobile Imaging SystemZiehm Imaging, Inc. · 2006
- 7 generations backK073346 Ziehm Vision 2Ziehm Imaging, Inc. · 2008 · Recalled
- 6 generations backK083545 Ziehm Vision RFDZiehm Imaging, Inc. · 2009 · Recalled
- 5 generations backK132904 Ziehm Vision RFDZiehm Imaging GmbH · 2013 · Recalled
- 4 generations backK142740 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2015 · Recalled
- 3 generations backK202360 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2020
- 2 generations backK231701 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2023 · Recalled
- 1 generation backK243303 Ziehm Vision RFD 3DZiehm Imaging GmbH · 2025
- This deviceK252735 C-beamPulmera, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K003266 | Siremobil Iso-C 3D | Siemens Medical Solutions USA, Inc. | 2000 | — |
| −9 | K032280 | Siremobil Iso-C 3D | Siemens AG | 2003 | — |
| −8 | K061310 | Ziehm Vario 3D Digital Mobile Imaging System | Ziehm Imaging, Inc. | 2006 | — |
| −7 | K073346 | Ziehm Vision 2 | Ziehm Imaging, Inc. | 2008 | 5 |
| −6 | K083545 | Ziehm Vision RFD | Ziehm Imaging, Inc. | 2009 | 3 |
| −5 | K132904 | Ziehm Vision RFD | Ziehm Imaging GmbH | 2013 | 1 |
| −4 | K142740 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2015 | 1 |
| −3 | K202360 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2020 | — |
| −2 | K231701 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2023 | 1 |
| −1 | K243303 | Ziehm Vision RFD 3D | Ziehm Imaging GmbH | 2025 | — |
| 0 (this device) | K252735 | C-beam | Pulmera, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 1 |
| 2002 | 1 | 1 |
| 2003 | 1 | 1 |
| 2006 | 2 | 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.
3 devices in this family have 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243303 | Ziehm Vision RFD 3DSummary page 5…uent Product Codes: JAK Primary Predicate Device Trade/Device Name: Ziehm Vision RFD 3D Manufacturer: Ziehm Imaging GmbH 510(k) Clearance K243303 Clearance Date 01/21/2025 Regulation Name: Image-intensified fluoroscopic X-ray System Classification Panel… | 2025 |
| † | K191394 | ILLUMISITE Platform | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
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.
- K024012Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003 · 8 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 8 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 8 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 10 of the 17 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K243303.
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 C-Beam device is intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative
surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but
not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the
spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm
positioning data is required for Computer-Assisted Surgery procedures. The visualization of such anatomical structures
assists the clinician in the clinical outcome.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252735: C-beam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252735
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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