# K261725: OtoCompanion (Version 1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Ironsides Medical, Inc.
- Decided: Sep 21, 2026 after 118 days
- Product code: SHL (Ear, Nose, And Throat Image Analyzer)
- Device class: 2
- Regulation: 21 CFR 874.4775
- 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 DEN250014 (2026). 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)
- DEN250014: Tyto Insights for Eardrum Bulging Detection, Tyto Care, Ltd. (2026) Summary page 5.

## Indications for use
OtoCompanion software is intended to accurately detect the presence of middle ear fluid (e.g., otitis media with effusion) that may be associated with acute ear infection. The instrument is designed for use by doctors and other medical professionals on pediatric patients (6 months to 21 years).

Source page: https://510kreport.com/device/K261725
Methodology: https://510kreport.com/methodology