510(k) · Cleared
ClearedSiemens Integrated Operating System (Sios)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Corp. · ODA Endoscopic Central Control Unit
Cleared on Aug 10, 2000 as substantially equivalent to K981993 (The Olympus Optical Co., 1998) after a 238-day review. Its family tree reaches back 4 generations to 1980. 4 of the 182 devices in its family, counting itself, have a Class I recall. 157 later devices descend from it.
- Decided
- Aug 10, 2000
- Review
- 238 days
- Class
- Class II
- Product code
- ODA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K801623 (1980). 24 ancestors in all. 157 later devices descend from it, 2 citing it directly. 4 of the 182 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 3 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 2 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 1 generation backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- This deviceK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- Descendant · cites it directly · 154 of its ownK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 72 of its ownK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 69 of its ownK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
Showing 5 of 157 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 157 · See all- K052202Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · cites it directly154descendants
- K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on80descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on78descendants
- K073290Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · 2 generations on72descendants
- K090745Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · 3 generations on69descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −3 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −2 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −1 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| 0 (this device) | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| +1 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| +2 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +3 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +2 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| +3 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 10 | 0 |
| 2014 | 11 | 0 |
| 2015 | 7 | 0 |
| 2016 | 12 | 1 |
| 2017 | 6 | 2 |
| 2018 | 11 | 0 |
| 2019 | 7 | 0 |
| 2020 | 12 | 1 |
| 2021 | 9 | 0 |
| 2022 | 10 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 13 | 0 |
| 2026 | 9 | 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.
4 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 ODA device
- #1 K203566 Tablet Applicationscore 6.7 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K981993 | Olympus Integrated Endosurgery System EndoalphaSummary page 4…. The package is substantially equivalent to the following devices: rTangem A "HERMES ™™ Operating Room Control Center and Accessories EndoALPHA '™ Integrated Olympus K981993 8121798 Endosurgery System 510(k) for Siemens Integrated Operating System (SIOS) Page 66 Siemens Medical Systems, Inc. === Page… | 1998 |
| Kept off the family tree | K081798 | EndoALPHA Integrated Endosurgery System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (157)
See all 1572 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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.
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 7 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 7 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 8 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 24 ancestors has a recall.
- Of its descendants, K052202 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 154 descendants of its own.
- 4 other devices also cite its predicate K981993.
How does its category compare?
All ODA devicesODA Endoscopic Central Control Unit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ODA
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · ODA
Too few ODA 510(k)s in any year since 2007 to give a median.
Recalls per year · ODA
No recall names ODA since 2007.
Adverse event reports per year · ODA
3in 2025
MAUDE reports naming product code ODA, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SIOS product is intended to optimize procedures in the operating room by providing consistent pre-operative, intra-operative and post-operative equipment control, image and data handling, and networking capabilities,
The SIOS product is limited to use with the following products:
(1) Wolf Endocam - 3CCD Endocam 5507,
(2) Wolf Light Source - Auto-CP 5131,
(3) Wolf Insufflator - Laparo CO₂ Patu 2332, and
(4) Maquet OR Table - ALPHAMAQUET 1150.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994231: Siemens Integrated Operating System (Sios).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994231
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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