510(k) · Cleared
ClearedOsram Itos
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osram Sylvania, Inc. · ERA Otoscope
Cleared on Oct 27, 2011 as substantially equivalent to K781029 (Welch Allyn, Inc., 1978) after a 266-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Oct 27, 2011
- Review
- 266 days
- Class
- Class I
- Product code
- ERA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K781029 (1978). No later device cites it as a predicate yet.
- Root · 1 generation backK781029 Otoscope, Diag. Models 20100 & 20200Welch Allyn, Inc. · 1978
- This deviceK110326 Osram ItosOsram Sylvania, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K781029 | Otoscope, Diag. Models 20100 & 20200 | Welch Allyn, Inc. | 1978 | — |
| 0 (this device) | K110326 | Osram Itos | Osram Sylvania, Inc. | 2011 | — |
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 ERA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K781029 | Otoscope, Diag. Models 20100 & 20200Summary page 2…ification Name: Otoscope Device Class: Class I Classification Panel: Ear, Nose, and Throat Product Code: ERA Predicate Device: Welch Allyn Otoscope Diag. Model 20200 K781029 Welch Allyn Otoscope Models 20000, 21700, 25020 501(k) numbers unknown Indications for Use: The OSRAM ITOS 0-03100 is intended… | 1978 |
| * | — | Welch Allyn Otoscope Model 20000 Named without a submission number | |
| * | — | Welch Allyn Otoscope Model 21700 Named without a submission number | |
| * | — | Welch Allyn Otoscope Model 25020 Named without a submission number |
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 ERA devicesERA Otoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ERA
2in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · ERA
Too few ERA 510(k)s in any year since 2007 to give a median.
Recalls per year · ERA
No recall names ERA since 2007.
Adverse event reports per year · ERA
2in 2025
MAUDE reports naming product code ERA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OSRAM ITOS 0-3100 is intended to provide illumination of the ear canal and tympanic membrane for observation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110326: Osram Itos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110326
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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