510(k) · Cleared
ClearedSonosentry
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Isonea, Ltd. · PHZ Abnormal Breath Sound Device
Cleared on Aug 19, 2014 as substantially equivalent to K090863 (Karmelsonix, 2009) after a 470-day review. Its family tree reaches back 3 generations to 1998. 7 later devices descend from it.
- Decided
- Aug 19, 2014
- Review
- 470 days
- Class
- Class II
- Product code
- PHZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980878 (1998). 4 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK980878 Pulmotrack,Model 1010Karmel Medical Acoustic Technologies, Ltd. · 1998
- 2 generations backK012387 STG Multichannel Lung Sound Analysis SystemStethographics, Inc. · 2002
- 1 generation backK090863 Personal WheezometerKarmelsonix · 2009
- This deviceK131285 SonosentryIsonea, Ltd. · 2014
- Descendant · cites it directly · 6 of its ownK202062 wheezo WheezeRate DetectorRespiri Limited · 2021
- Descendant · 2 generations on · 5 of its ownK221614 TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023
- Descendant · 3 generations on · 4 of its ownK232237 Tyto Insights for Wheeze DetectionTyto Care, Ltd. · 2023
- Descendant · 4 generations on · 1 of its ownK240555 Tyto Insights for Crackles DetectionTyto Care, Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK260140 Aevice Wheeze Detection ModuleAevice Health Pte., Ltd. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K202062wheezo WheezeRate DetectorRespiri Limited · 2021 · cites it directly6descendants
- K221614TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023 · 2 generations on5descendants
- K232237Tyto Insights for Wheeze DetectionTyto Care, Ltd. · 2023 · 3 generations on4descendants
- K240555Tyto Insights for Crackles DetectionTyto Care, Ltd. · 2024 · 4 generations on1descendant
- K260140Aevice Wheeze Detection ModuleAevice Health Pte., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980878 | Pulmotrack,Model 1010 | Karmel Medical Acoustic Technologies, Ltd. | 1998 | — |
| −2 | K012387 | STG Multichannel Lung Sound Analysis System | Stethographics, Inc. | 2002 | — |
| −1 | K090863 | Personal Wheezometer | Karmelsonix | 2009 | — |
| 0 (this device) | K131285 | Sonosentry | Isonea, Ltd. | 2014 | — |
| +1 | K202062 | wheezo WheezeRate Detector | Respiri Limited | 2021 | — |
| +2 | K221614 | TytoCare Lung Sounds Analyzer | Tyto Care, Ltd. | 2023 | — |
| +3 | K232237 | Tyto Insights for Wheeze Detection | Tyto Care, Ltd. | 2023 | — |
| +4 | K240555 | Tyto Insights for Crackles Detection | Tyto Care, Ltd. | 2024 | — |
| +4 | K260140 | Aevice Wheeze Detection Module | Aevice Health Pte., Ltd. | 2026 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K090863 | Personal WheezometerSummary page 5…cate Device Manufacturer KarmelSonix (now known as iSonea Ltd.) Device Name Personal Wheezometer™ 510(k) Number K090863 Clearance Date September 21, 2009 Indications for Use The Personal Wheezometer™ is intended for quan… | 2009 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202062 | wheezo WheezeRate Detector | 2021 | 6 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K202062 (Respiri Limited, 2021) has gone furthest, with 6 descendants of its own.
How does its category compare?
All PHZ devicesPHZ Abnormal Breath Sound Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 SonoSentryTM WheezeRateTM Detector is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRateTM in adults and children (2 years and older). WheezeRateTM represents the percentage of abnormal breath sound detected during the measurement time. A licensed health care professional’s advice is required to understand the meaning and importance of the SonoSentryTM readings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131285 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131285: Sonosentry.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131285
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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