510(k) · Cleared
ClearedCios Select
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 Nov 4, 2025 as substantially equivalent to K223410 (Siemens Medical Solutions USA, Inc., 2022) after a 281-day review. Its family tree reaches back 14 generations to 1980.
- Decided
- Nov 4, 2025
- Review
- 281 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K801623 (1980). 80 ancestors in all. No later device cites it as a predicate yet.
- Root · 14 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 10 generations between
- 3 generations backK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 2 generations backK210309 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- 1 generation backK223410 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2022
- This deviceK250241 Cios SelectSiemens Medical Solutions USA, Inc. · 2025
Show all 14 generations
- Root · 14 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 13 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 12 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 11 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 10 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 9 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 8 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 7 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 6 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 5 generations backK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
- 4 generations backK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- 3 generations backK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 2 generations backK210309 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2021 · Recalled
- 1 generation backK223410 Cios Select (VA21) Flat PanelSiemens Medical Solutions USA, Inc. · 2022
- This deviceK250241 Cios SelectSiemens Medical Solutions USA, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −13 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −12 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −11 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −10 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −9 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −8 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −7 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −6 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| −5 | K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | 2017 | 14 |
| −4 | K181560 | Cios Alpha | Siemens Medical Systems USA, Inc. | 2018 | 7 |
| −3 | K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| −2 | K210309 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2021 | 1 |
| −1 | K223410 | Cios Select (VA21) Flat Panel | Siemens Medical Solutions USA, Inc. | 2022 | — |
| 0 (this device) | K250241 | Cios Select | 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 | 4 | 0 |
| 2018 | 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.
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? (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 |
|---|---|---|---|
| * | K223410 | Cios Select (VA21) Flat PanelSummary page 6…Codes: OWB, OXO, JAA 4. Legally Marketed Predicate Device Trade Name: Cios Select 510(k) Clearance K223410 Clearance Date December 7, 2022 Classification Name: Image-intensified fluoroscopic x-ray Sys… | 2022 |
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 80 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 Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care, and in Veterinary Medicine.
The Cios Select can operate in three different modes, Digital Radiography, Fluoroscopy, and Pulsed Fluoroscopy which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250241: Cios Select.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250241
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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