510(k) · Cleared
ClearedTyto Insights for Crackles Detection
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 Jul 2, 2024 as substantially equivalent to K232237 (Tyto Care, Ltd., 2023) after a 125-day review. Its family tree reaches back 7 generations to 1998. 1 later device descends from it.
- Decided
- Jul 2, 2024
- Review
- 125 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. 1 later device descends from it, 1 citing it directly.
- 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 deviceK240555 Tyto Insights for Crackles DetectionTyto Care, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK243567 Tyto Insights for Rhonchi DetectionTyto Care, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243567Tyto Insights for Rhonchi DetectionTyto Care, Ltd. · 2025 · cites it directly0descendants
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) | K240555 | Tyto Insights for Crackles Detection | Tyto Care, Ltd. | 2024 | — |
| +1 | K243567 | Tyto Insights for Rhonchi Detection | Tyto Care, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 Primary 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 |
| † | K091732 | Vrlxp, Model XP | 2010 |
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 |
|---|---|---|---|
| K243567 | Tyto Insights for Rhonchi Detection | 2025 | 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?
- The line of descent spans 26 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.
- Of its descendants, K243567 (Tyto Care, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 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. 2024, 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 Crackles Detection 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 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Crackle” is suspected. It is not…
Read the full statement (113 words)
The Tyto Insights for Crackles Detection 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 510k cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Crackle” 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 Crackles 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/K240555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240555: Tyto Insights for Crackles Detection.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240555
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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