510(k) · Cleared
ClearedOtoCompanion (Version 1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ironsides Medical, Inc. · SHL Ear, Nose, And Throat Image Analyzer
Cleared on Sep 21, 2026 as substantially equivalent to DEN250014 (Tyto Care, Ltd., 2026) after a 118-day review. Its family tree reaches back 1 generation to 2026.
- Decided
- Sep 21, 2026
- Review
- 118 days
- Class
- Class II
- Product code
- SHL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN250014 (2026). No later device cites it as a predicate yet.
- Root · 1 generation backDEN250014 Tyto Insights for Eardrum Bulging DetectionTyto Care, Ltd. · 2026
- This deviceK261725 OtoCompanion (Version 1.0)Ironsides Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN250014 | Tyto Insights for Eardrum Bulging Detection | Tyto Care, Ltd. | 2026 | — |
| 0 (this device) | K261725 | OtoCompanion (Version 1.0) | Ironsides Medical, Inc. | 2026 | — |
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 SHL? 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? (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 |
|---|---|---|---|
| * | DEN250014 | Tyto Insights for Eardrum Bulging DetectionSummary page 5…/ CFR SHL / 21 CFR 874.4775 Device Class Class II Predicate Device Tyto Insights for Eardrum Bulging Detection (DEN250014, Tyto Care Ltd.) 3. Predicate Device The predicate device is Tyto Insights for Eardrum Bulgi… | 2026 |
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 SHL devicesSHL Ear, Nose, And Throat Image Analyzer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHL
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHL
Too few SHL 510(k)s in any year since 2007 to give a median.
Recalls per year · SHL
No recall names SHL since 2007.
Adverse event reports per year · SHL
No MAUDE report names SHL since 2007.
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 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261725 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261725: OtoCompanion (Version 1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261725
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026