510(k) · Cleared
ClearedPersonal Wheezometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karmelsonix · BZM Calculator, Pulmonary Function Interpretor (Diagnostic)
Cleared on Sep 21, 2009 as substantially equivalent to K071955 (Karmelsonix, 2007) and 1 other predicate after a 175-day review. Its family tree reaches back 2 generations to 1998. 8 later devices descend from it.
- Decided
- Sep 21, 2009
- Review
- 175 days
- Class
- Class II
- Product code
- BZM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K980878 (1998). 3 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK980878 Pulmotrack,Model 1010Karmel Medical Acoustic Technologies, Ltd. · 1998
- 1 generation backK012387 STG Multichannel Lung Sound Analysis SystemStethographics, Inc. · 2002
- This deviceK090863 Personal WheezometerKarmelsonix · 2009
- Descendant · cites it directly · 7 of its ownK131285 SonosentryIsonea, Ltd. · 2014
- Descendant · 2 generations on · 6 of its ownK202062 wheezo WheezeRate DetectorRespiri Limited · 2021
- Descendant · 3 generations on · 5 of its ownK221614 TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023
- Descendant · 4 generations on · 4 of its ownK232237 Tyto Insights for Wheeze DetectionTyto Care, Ltd. · 2023
- Descendant · 5 generations on · 1 of its ownK240555 Tyto Insights for Crackles DetectionTyto Care, Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K131285SonosentryIsonea, Ltd. · 2014 · cites it directly7descendants
- K202062wheezo WheezeRate DetectorRespiri Limited · 2021 · 2 generations on6descendants
- K221614TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023 · 3 generations on5descendants
- K232237Tyto Insights for Wheeze DetectionTyto Care, Ltd. · 2023 · 4 generations on4descendants
- K240555Tyto Insights for Crackles DetectionTyto Care, Ltd. · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K980878 | Pulmotrack,Model 1010 | Karmel Medical Acoustic Technologies, Ltd. | 1998 | — |
| −1 | K012387 | STG Multichannel Lung Sound Analysis System | Stethographics, Inc. | 2002 | — |
| 0 (this device) | K090863 | Personal Wheezometer | Karmelsonix | 2009 | — |
| +1 | K131285 | Sonosentry | Isonea, Ltd. | 2014 | — |
| +2 | K202062 | wheezo WheezeRate Detector | Respiri Limited | 2021 | — |
| +3 | K221614 | TytoCare Lung Sounds Analyzer | Tyto Care, Ltd. | 2023 | — |
| +4 | K232237 | Tyto Insights for Wheeze Detection | Tyto Care, Ltd. | 2023 | — |
| +5 | K240555 | Tyto Insights for Crackles Detection | Tyto Care, Ltd. | 2024 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 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 BZM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K071955 | Wim-PC, Model 1010Summary page 1…(PW) is intended to be a home use version of the PulnmoTrackg (K980878) and PulmoTrack model 2010 (WIM-PC) (k071955), providing wheeze-rate information for both home and clinical settings.… | 2007 |
| * | K012387 | STG Multichannel Lung Sound Analysis System | 2002 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131285 | Sonosentry | 2014 | 7 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K131285 (Isonea, Ltd., 2014) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K071955.
How does its category compare?
All BZM devicesBZM Calculator, Pulmonary Function Interpretor (Diagnostic): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · BZM
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · BZM
Too few BZM 510(k)s in any year since 2007 to give a median.
Recalls per year · BZM
No recall names BZM since 2007.
Adverse event reports per year · BZM
1in 2007
MAUDE reports naming product code BZM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 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 | 0 | — | 0 | — |
What is it indicated for?
The PERSONAL WHEEZOMETERTM is intended for quantifying the presence of wheezing. This device should be used under the direction of a physician or licensed healthcare professional for monitoring acoustic pulmonary functions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090863 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090863: Personal Wheezometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090863
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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