510(k) · Cleared
ClearedKarl Storz OR1™ SCB Control (WU300)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · ODA Endoscopic Central Control Unit
Cleared on Oct 3, 2023 as substantially equivalent to K994348 (KARL STORZ Endoscopy-America, Inc., 2000) after a 54-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Oct 3, 2023
- Review
- 54 days
- Class
- Class II
- Product code
- ODA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K994348 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK994348 Ksea SCB-RuiKARL STORZ Endoscopy-America, Inc. · 2000
- This deviceK232406 Karl Storz OR1™ SCB Control (WU300)Karl Storz SE & CO. KG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994348 | Ksea SCB-Rui | KARL STORZ Endoscopy-America, Inc. | 2000 | — |
| 0 (this device) | K232406 | Karl Storz OR1™ SCB Control (WU300) | Karl Storz SE & CO. KG | 2023 | — |
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 |
|---|---|---|---|
| * | K994348 | Ksea SCB-RuiSummary page 5…opic Central Control Unit Regulatory Class: II Product Code: ODA, FET Regulation: 876.1500 Predicate Device(s): Primary Predicate Device: KSEA SCB-RUI K994348 The predicate device has not been subject to a design-related recall. 1. Device Description The K… | 2000 |
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?
- Its one ancestor has no 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. 2023, 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?
The KARL STORZ OR TM SCB CONTROL provides central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232406: Karl Storz OR1™ SCB Control (WU300).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232406
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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