510(k) · Cleared
ClearedOEC One CFD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Hualun Medical Systems Co., Ltd. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Nov 26, 2025 as substantially equivalent to K240828 (Ge Hualun Medical Systems Co., Ltd., 2024) after a 58-day review. Its family tree reaches back 9 generations to 2002. 2 of the 11 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 26, 2025
- Review
- 58 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K021049 (2002). 10 ancestors in all. No later device cites it as a predicate yet. 2 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 5 generations between
- 3 generations backK172700 OEC OneGe Hualun Medical Systems Co., Ltd. · 2017
- 2 generations backK182626 OEC OneGe Hualun Medical Systems Co., Ltd. · 2018
- 1 generation backK240828 OEC One ASDGe Hualun Medical Systems Co., Ltd. · 2024
- This deviceK253269 OEC One CFDGe Hualun Medical Systems Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 8 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 7 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 6 generations backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- 5 generations backK111551 Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc. · 2011 · Recalled
- 4 generations backK123603 Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715…Ge Healthcare Surgery GE Oec Medical Systems, Inc. · 2013 · Recalled
- 3 generations backK172700 OEC OneGe Hualun Medical Systems Co., Ltd. · 2017
- 2 generations backK182626 OEC OneGe Hualun Medical Systems Co., Ltd. · 2018
- 1 generation backK240828 OEC One ASDGe Hualun Medical Systems Co., Ltd. · 2024
- This deviceK253269 OEC One CFDGe Hualun Medical Systems Co., Ltd. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −8 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −7 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −6 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| −5 | K111551 | Oec (R) 9800, Oec (R) 9800 Plus | Ge Oec Medical Systems, Inc. | 2011 | 9 |
| −4 | K123603 | Oec Brivo 865 Advance, Oec Brivo 785 Essential, and Oec Brivo 715 Prime | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2013 | 5 |
| −3 | K172700 | OEC One | Ge Hualun Medical Systems Co., Ltd. | 2017 | — |
| −2 | K182626 | OEC One | Ge Hualun Medical Systems Co., Ltd. | 2018 | — |
| −1 | K240828 | OEC One ASD | Ge Hualun Medical Systems Co., Ltd. | 2024 | — |
| 0 (this device) | K253269 | OEC One CFD | Ge Hualun Medical Systems Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
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.
2 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 OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 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? (2 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 · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 7 of the 10 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The product is designed to provide fluoroscopic and digital spot images of adult and pediatric patient populations during diagnostic, interventional, and surgical procedures. Examples of a clinical application may include: orthopedic, gastrointestinal, endoscopic, urologic, neurologic, vascular, critical care, and emergency procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253269 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253269: OEC One CFD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253269
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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