510(k) · Cleared
ClearedRiwo Net Operating Operating Control System, Model #5590
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · ODA Endoscopic Central Control Unit
Cleared on Sep 18, 2002 as substantially equivalent to K994231 (Siemens Medical Corp., 2000) and 3 other predicates after a 237-day review. Its family tree reaches back 5 generations to 1980. 1 later device descends from it.
- Decided
- Sep 18, 2002
- Review
- 237 days
- Class
- Class II
- Product code
- ODA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K801623 (1980). 31 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 4 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 3 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 2 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 1 generation backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- This deviceK020255 Riwo Net Operating Operating Control System, Model #5590Richard Wolf Medical Instruments Corp. · 2002
- Descendant · cites it directly · 0 of its ownK151282 core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp. · 2016
Most influential descendants
Showing 1 of 1 · See all- K151282core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −4 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −3 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −2 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −1 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| 0 (this device) | K020255 | Riwo Net Operating Operating Control System, Model #5590 | Richard Wolf Medical Instruments Corp. | 2002 | — |
| +1 | K151282 | core nova Complete Operating Room Endoscopy | Richard Wolf Medical Instruments Corp. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 ODA? 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? (5)
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 |
|---|---|---|---|
| * | K994231 | Siemens Integrated Operating System (Sios)Summary page 4…ories remote and voice control, CAN bus Information on devices to which substantial equivalence is claimed: b?:gf;c)r Tradc or proprietary or model name Manufacturcr 1 K994231 |1 SIEMENS Integrated Operating System (SIOS) 1 Siemens 2 K981993 |2 EndoALPHA Integrated Endosurgery System 2 Olympus 3 K980787… | 2000 |
| * | K981993 | Olympus Integrated Endosurgery System EndoalphaSummary page 4…which substantial equivalence is claimed: b?:gf;c)r Tradc or proprietary or model name Manufacturcr 1 K994231 |1 SIEMENS Integrated Operating System (SIOS) 1 Siemens 2 K981993 |2 EndoALPHA Integrated Endosurgery System 2 Olympus 3 K980787 |3 HERMES Operating Room Control Center 3 Computer Motion 4 4 Oper… | 1998 |
| * | K980787 | Hermes Operating Room Control Center with the Wom 20L InsufflatorSummary page 4…proprietary or model name Manufacturcr 1 K994231 |1 SIEMENS Integrated Operating System (SIOS) 1 Siemens 2 K981993 |2 EndoALPHA Integrated Endosurgery System 2 Olympus 3 K980787 |3 HERMES Operating Room Control Center 3 Computer Motion 4 4 Operation Room Control OR1/ SCB PC 4 Karl Storz 5 K002328 |5 SI0S-I… | 1998 |
| * | K002328 | Sios-Interface for Auto Light Projector, Sios-Interface for 3 CCD Endocam…Summary page 4…doALPHA Integrated Endosurgery System 2 Olympus 3 K980787 |3 HERMES Operating Room Control Center 3 Computer Motion 4 4 Operation Room Control OR1/ SCB PC 4 Karl Storz 5 K002328 |5 SI0S-Interface for Light Projector, Camera, Insufflator 5 Richard Wolf 12-1 Lol L 1.0 2.0 3.0 4.0 5.0 6.… | 2001 |
| * | — | Operation Room Control OR1/ SCB PC Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151282 | core nova Complete Operating Room Endoscopy | 2016 | 0 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- None of the 31 ancestors has a recall.
- Of its descendants, K151282 (Richard Wolf Medical Instruments Corp., 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K994231.
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 RIWO NET SYSTEM 5590 is used for controlling an operating system by voice control, touch screen monitor or remote control unit in diagnostic and therapeutic endoscopy.
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/K020255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020255: Riwo Net Operating Operating Control System, Model #5590.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020255
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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