# K083598: Karl Storz VOICE1 SCB R-UI Speech Control Application

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: May 29, 2009 after 175 days
- Product code: ODA (Endoscopic Central Control Unit)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003113 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003113: Ksea SCB-Rui Sco, KARL STORZ Endoscopy-America, Inc. (2001) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K083598
Methodology: https://510kreport.com/methodology