510(k) · Cleared
Clearedcore nova Complete Operating Room Endoscopy
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 Jan 12, 2016 as substantially equivalent to K020255 (Richard Wolf Medical Instruments Corp., 2002) after a 243-day review. Its family tree reaches back 6 generations to 1980.
- Decided
- Jan 12, 2016
- Review
- 243 days
- Class
- Class II
- Product code
- ODA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K801623 (1980). 32 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 5 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 4 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 3 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 2 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 1 generation backK020255 Riwo Net Operating Operating Control System, Model #5590Richard Wolf Medical Instruments Corp. · 2002
- This deviceK151282 core nova Complete Operating Room EndoscopyRichard Wolf Medical Instruments Corp. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −5 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −4 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −3 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −2 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −1 | K020255 | Riwo Net Operating Operating Control System, Model #5590 | Richard Wolf Medical Instruments Corp. | 2002 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K020255 | Riwo Net Operating Operating Control System, Model #5590Summary page 4…ence is claimed: 510(k) Trade or proprietary or model name Manufacturer Number 1 RIWO NET Operating Control System 1 K020255 1 Richard Wolf Model # 5590 5. 510(k) Summary… | 2002 |
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 36 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- None of the 32 ancestors has a recall.
How does its category compare?
All ODA devicesODA Endoscopic Central Control Unit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
Core.nova (core.browser, core.connect with driver, IR Transceiver, core.media, and core.portal) are components used for
the central control of integrated medical devices and accessories in one central location within the operating room.
In particular core.nova is used for the control of connected compatible OR equipment, like OR-lamp, OR-camera, OR-
table, insufflator, or video- and documentation system intended for diagnostic and therapeutic medical conditions. The
connected devices (Richard Wolf or third party) can be controlled by control terminals (with touch screen), or the control
mechanism on actual device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151282: core nova Complete Operating Room Endoscopy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151282
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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