510(k) · Cleared
Clearedwheezo WheezeRate Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Respiri Limited · PHZ Abnormal Breath Sound Device
Cleared on Mar 11, 2021 as substantially equivalent to K131285 (Isonea, Ltd., 2014) after a 227-day review. Its family tree reaches back 4 generations to 1998. 6 later devices descend from it.
- Decided
- Mar 11, 2021
- Review
- 227 days
- Class
- Class II
- Product code
- PHZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K980878 (1998). 5 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK980878 Pulmotrack,Model 1010Karmel Medical Acoustic Technologies, Ltd. · 1998
- 3 generations backK012387 STG Multichannel Lung Sound Analysis SystemStethographics, Inc. · 2002
- 2 generations backK090863 Personal WheezometerKarmelsonix · 2009
- 1 generation backK131285 SonosentryIsonea, Ltd. · 2014
- This deviceK202062 wheezo WheezeRate DetectorRespiri Limited · 2021
- Descendant · cites it directly · 5 of its ownK221614 TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023
- Descendant · 2 generations on · 4 of its ownK232237 Tyto Insights for Wheeze DetectionTyto Care, Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK240555 Tyto Insights for Crackles DetectionTyto Care, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK260140 Aevice Wheeze Detection ModuleAevice Health Pte., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK252844 Tyto Insights for Wheeze Detection (with PCCP)Tyto Care, Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K221614TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023 · cites it directly5descendants
- K232237Tyto Insights for Wheeze DetectionTyto Care, Ltd. · 2023 · 2 generations on4descendants
- K240555Tyto Insights for Crackles DetectionTyto Care, Ltd. · 2024 · 3 generations on1descendant
- K260140Aevice Wheeze Detection ModuleAevice Health Pte., Ltd. · 2026 · 3 generations on0descendants
- K252844Tyto Insights for Wheeze Detection (with PCCP)Tyto Care, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K980878 | Pulmotrack,Model 1010 | Karmel Medical Acoustic Technologies, Ltd. | 1998 | — |
| −3 | K012387 | STG Multichannel Lung Sound Analysis System | Stethographics, Inc. | 2002 | — |
| −2 | K090863 | Personal Wheezometer | Karmelsonix | 2009 | — |
| −1 | K131285 | Sonosentry | Isonea, Ltd. | 2014 | — |
| 0 (this device) | K202062 | wheezo WheezeRate Detector | Respiri Limited | 2021 | — |
| +1 | K221614 | TytoCare Lung Sounds Analyzer | Tyto Care, Ltd. | 2023 | — |
| +2 | K232237 | Tyto Insights for Wheeze Detection | Tyto Care, Ltd. | 2023 | — |
| +3 | K240555 | Tyto Insights for Crackles Detection | Tyto Care, Ltd. | 2024 | — |
| +3 | K260140 | Aevice Wheeze Detection Module | Aevice Health Pte., Ltd. | 2026 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K131285 | SonosentrySummary page 4…tor Product Code PHZ Classification of Device II Review Panel Anesthesiology Predicate Device SonoSentry (K131285) 4. INDICATIONS FOR USE STATEMENT wheezo is intended to detect and record abnormal breath sounds (continuous adventitious brea… | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221614 | TytoCare Lung Sounds Analyzer | 2023 | 5 |
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 23 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K221614 (Tyto Care, Ltd., 2023) has gone furthest, with 5 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. 2021, 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?
wheezo is intended to detect and record abnormal breath sounds (continuous adventitious breath sounds/CABS) at the windpipe (trachea), reported as WheezeRate in adults and children (2 years and older). A licensed health care professional’s advice is required to understand the meaning and importance of the wheezo readings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202062 · printed Nov 3, 2026
Cite this page
510(k) Report. “K202062: wheezo WheezeRate Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K202062
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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