510(k) · Cleared
ClearedTyto Insights for Wheeze Detection (with PCCP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyto Care, Ltd. · PHZ Abnormal Breath Sound Device
Cleared on Jun 2, 2026 as substantially equivalent to K232237 (Tyto Care, Ltd., 2023) after a 267-day review. Its family tree reaches back 7 generations to 1998.
- Decided
- Jun 2, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- PHZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K980878 (1998). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK980878 Pulmotrack,Model 1010Karmel Medical Acoustic Technologies, Ltd. · 1998
- 6 generations backK012387 STG Multichannel Lung Sound Analysis SystemStethographics, Inc. · 2002
- 5 generations backK090863 Personal WheezometerKarmelsonix · 2009
- 4 generations backK131285 SonosentryIsonea, Ltd. · 2014
- 3 generations backK202062 wheezo WheezeRate DetectorRespiri Limited · 2021
- 2 generations backK221614 TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023
- 1 generation backK232237 Tyto Insights for Wheeze DetectionTyto Care, Ltd. · 2023
- This deviceK252844 Tyto Insights for Wheeze Detection (with PCCP)Tyto Care, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K980878 | Pulmotrack,Model 1010 | Karmel Medical Acoustic Technologies, Ltd. | 1998 | — |
| −6 | K012387 | STG Multichannel Lung Sound Analysis System | Stethographics, Inc. | 2002 | — |
| −5 | K090863 | Personal Wheezometer | Karmelsonix | 2009 | — |
| −4 | K131285 | Sonosentry | Isonea, Ltd. | 2014 | — |
| −3 | K202062 | wheezo WheezeRate Detector | Respiri Limited | 2021 | — |
| −2 | K221614 | TytoCare Lung Sounds Analyzer | Tyto Care, Ltd. | 2023 | — |
| −1 | K232237 | Tyto Insights for Wheeze Detection | Tyto Care, Ltd. | 2023 | — |
| 0 (this device) | K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
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 PHZ? 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 PHZ device
- #1 K232237 Tyto Insights for Wheeze Detectionscore 17.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K232237 | Tyto Insights for Wheeze DetectionSummary page 5…Panel: Anesthesiology Predicate Device(s): Device name 510(k) No. Date of Clearance Tyto Insights for Wheeze K232237 December 13, 2023 Detection Reference Device(s): Device name 510(k) No.… | 2023 |
| † | K243567 | Tyto Insights for Rhonchi Detection | 2025 |
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?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K232237.
How does its category compare?
All PHZ devicesPHZ Abnormal Breath Sound Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · PHZ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHZ
Too few PHZ 510(k)s in any year since 2007 to give a median.
Recalls per year · PHZ
No recall names PHZ since 2007.
Adverse event reports per year · PHZ
No MAUDE report names PHZ 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 | 1 | — | 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 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Tyto Insights for Wheeze Detection (with PCCP) is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. It is not…
Read the full statement (114 words)
The Tyto Insights for Wheeze Detection (with PCCP) is an over-the-counter artificial intelligence (AI) enabled decision support software system used in the evaluation of lung sounds in adults and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other relevant patient data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252844 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252844: Tyto Insights for Wheeze Detection (with PCCP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252844
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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