510(k) · Cleared
ClearedCios Alpha; Cios Flow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jul 9, 2025 as substantially equivalent to K210055 (Siemens Medical Solutions USA, Inc., 2021) and 2 other predicates after a 54-day review. Its family tree reaches back 13 generations to 1980.
- Decided
- Jul 9, 2025
- Review
- 54 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K801623 (1980). 77 ancestors in all. No later device cites it as a predicate yet.
- Root · 13 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 9 generations between
- 3 generations backK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- 2 generations backK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 1 generation backK210055 Cios AlphaSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- This deviceK251520 Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc. · 2025
Show all 13 generations
- Root · 13 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 12 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 11 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 10 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 9 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 8 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 7 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 6 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 5 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 4 generations backK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
- 3 generations backK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- 2 generations backK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 1 generation backK210055 Cios AlphaSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- This deviceK251520 Cios Alpha; Cios FlowSiemens Medical Solutions USA, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −12 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −11 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −10 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −9 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −8 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −7 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −6 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −5 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| −4 | K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | 2017 | 14 |
| −3 | K181560 | Cios Alpha | Siemens Medical Systems USA, Inc. | 2018 | 7 |
| −2 | K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| −1 | K210055 | Cios Alpha | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
| 0 (this device) | K251520 | Cios Alpha; Cios Flow | Siemens Medical Solutions USA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 7 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 11 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2004 | 8 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2018 | 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? (3)
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 |
|---|---|---|---|
| * | K210055 | Cios AlphaSummary page 6…t Product Codes: JAA, OXO 4. Legally Marketed Primary Predicate Device Trade Name: Cios Alpha 510(k) Clearance K210055 Clearance Date February 05, 2021 Classification Name: Image-intensified fluoroscopic X-ray Sys… | 2021 |
| * | K203504 | Cios FlowSummary page 6…models will not be affected by any applicable issues. Trade Name: Cios Flow 510(k) Clearance K203504 Clearance Date December 22, 2020 Classification Name: Image-intensified fluoroscopic X-ra… | 2020 |
| * | K132094 | Cios AlphaSummary page 6…dels will not be affected by any applicable issues. Secondary Predicate Device: Trade Name: Cios Alpha 510(k) Clearance: K132094 Clearance Date: March 11, 2014 Classification Name: Image-intensified fluoroscopic X-ray S… | 2014 |
| † | K231692 | Ziehm Vision RFD | 2023 |
| † | K233748 | CIARTIC Move (VB10) | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 45 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 33 of the 77 ancestors have a recall of any class.
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. 2025, 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 Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include, but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. The patient population may include pediatric patients. The Cios Flow is a…
Read the full statement (110 words)
The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include, but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room procedures. The patient population may include pediatric patients.
The Cios Flow is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include, but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251520 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251520: Cios Alpha; Cios Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251520
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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