De Novo · Granted
GrantedTyto Insights for Eardrum Bulging Detection
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyto Care, Ltd. · SHL Ear, Nose, And Throat Image Analyzer
Granted on Mar 17, 2026 as a new device type through De Novo after a 330-day review. 1 later device descends from it.
- Decided
- Mar 17, 2026
- Review
- 330 days
- Class
- Class II
- Product code
- SHL
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN250014 Tyto Insights for Eardrum Bulging DetectionTyto Care, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK261725 OtoCompanion (Version 1.0)Ironsides Medical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261725OtoCompanion (Version 1.0)Ironsides Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN250014 | Tyto Insights for Eardrum Bulging Detection | Tyto Care, Ltd. | 2026 | — |
| +1 | K261725 | OtoCompanion (Version 1.0) | Ironsides Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA De Novo 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.
Top candidate predicates for a new SHL device
- #1 K261725 OtoCompanion (Version 1.0)score 12.0 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261725 | OtoCompanion (Version 1.0) | 2026 | 0 |
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?
- Of its descendants, K261725 (Ironsides Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
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?
Tyto Insights for Eardrum Bulging Detection is an over-the-counter web-based AI-enabled software analytics device intended to automatically detect the bulging of the eardrum in Otoscopic video recordings acquired by the compatible electronic otoscope, as identified in the product labeling, in patients aged 6 months and older. The device is not intended for diagnosis. A healthcare provider’s advice is required to understand the meaning of the Tyto Insights for Eardrum Bulging Detection result. Healthcare providers should consider the device result in conjunction with otoscopic recordings and other relevant patient data. The device is not intended to detect other abnormal otoscopic findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250014 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250014: Tyto Insights for Eardrum Bulging Detection.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250014
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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