510(k) · Cleared
ClearedKarl Storz VOICE1 SCB R-UI Speech Control Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · ODA Endoscopic Central Control Unit
Cleared on May 29, 2009 as substantially equivalent to K003113 (KARL STORZ Endoscopy-America, Inc., 2001) after a 175-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- May 29, 2009
- Review
- 175 days
- Class
- Class II
- Product code
- ODA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003113 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003113 Ksea SCB-Rui ScoKARL STORZ Endoscopy-America, Inc. · 2001
- This deviceK083598 Karl Storz VOICE1 SCB R-UI Speech Control ApplicationKARL STORZ Endoscopy-America, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003113 | Ksea SCB-Rui Sco | KARL STORZ Endoscopy-America, Inc. | 2001 | — |
| 0 (this device) | K083598 | Karl Storz VOICE1 SCB R-UI Speech Control Application | KARL STORZ Endoscopy-America, Inc. | 2009 | — |
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 |
|---|---|---|---|
| * | K003113 | Ksea SCB-Rui ScoSummary page 1…ame: Endoscope and accessories Regulation Number: 21 CFR 876.1500 Product Code: ODA Predicate Deviceqs): Karl Storz SCBR-U I Speech Control Option SCO (K003113) Device Description: The Karl Storz VOICE1® SCB R-UI Speech Control Application is an independent appli… | 2001 |
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. 2009, 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 VOICE1® SCB R-UI Speech Control Application is indicated for use in speech control of Karl Storz-designated devices and peripherals in conjunction with the Karl Storz SCB® R-UI software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083598 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083598: Karl Storz VOICE1 SCB R-UI Speech Control Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083598
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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