# K110326: Osram Itos

- Pathway: 510(k) (Traditional)
- Applicant: Osram Sylvania, Inc.
- Decided: Oct 27, 2011 after 266 days
- Product code: ERA (Otoscope)
- Device class: 1
- Regulation: 21 CFR 874.4770
- 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 K781029 (1978). 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)
- K781029: Otoscope, Diag. Models 20100 & 20200, Welch Allyn, Inc. (1978) Summary page 2.
- (no number) Welch Allyn Otoscope Model 20000: named in the summary without a submission number
- (no number) Welch Allyn Otoscope Model 21700: named in the summary without a submission number
- (no number) Welch Allyn Otoscope Model 25020: named in the summary without a submission number

## Indications for use
The OSRAM ITOS 0-3100 is intended to provide illumination of the ear canal and tympanic membrane for observation.

Source page: https://510kreport.com/device/K110326
Methodology: https://510kreport.com/methodology