510(k) · Cleared
ClearedWim-PC, Model 1010
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 Nov 1, 2007 as substantially equivalent to K980878 (Karmel Medical Acoustic Technologies, Ltd., 1998) after a 108-day review. Its family tree reaches back 1 generation to 1998. 17 later devices descend from it.
- Decided
- Nov 1, 2007
- Review
- 108 days
- Class
- Class II
- Product code
- BZM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980878 (1998). 17 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK980878 Pulmotrack,Model 1010Karmel Medical Acoustic Technologies, Ltd. · 1998
- This deviceK071955 Wim-PC, Model 1010Karmelsonix · 2007
- Descendant · cites it directly · 8 of its ownK090863 Personal WheezometerKarmelsonix · 2009
- Descendant · 2 generations on · 7 of its ownK131285 SonosentryIsonea, Ltd. · 2014
- Descendant · 3 generations on · 6 of its ownK202062 wheezo WheezeRate DetectorRespiri Limited · 2021
- Descendant · cites it directly · 6 of its ownK101022 Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010
- Descendant · 4 generations on · 5 of its ownK221614 TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K090863Personal WheezometerKarmelsonix · 2009 · cites it directly8descendants
- K131285SonosentryIsonea, Ltd. · 2014 · 2 generations on7descendants
- K202062wheezo WheezeRate DetectorRespiri Limited · 2021 · 3 generations on6descendants
- K101022Pulmotrack 5050 Wholter, Model 5050Karmelsonix · 2010 · cites it directly6descendants
- K221614TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980878 | Pulmotrack,Model 1010 | Karmel Medical Acoustic Technologies, Ltd. | 1998 | — |
| 0 (this device) | K071955 | Wim-PC, Model 1010 | Karmelsonix | 2007 | — |
| +1 | K090863 | Personal Wheezometer | Karmelsonix | 2009 | — |
| +2 | K131285 | Sonosentry | Isonea, Ltd. | 2014 | — |
| +3 | K202062 | wheezo WheezeRate Detector | Respiri Limited | 2021 | — |
| +1 | K101022 | Pulmotrack 5050 Wholter, Model 5050 | Karmelsonix | 2010 | — |
| +4 | K221614 | TytoCare Lung Sounds Analyzer | Tyto Care, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K980878 | Pulmotrack,Model 1010Summary page 2…Y§C7A \ c\% 2 KarmelSonix Israel Ltd Laptop PC unit with Data Analysis software. Predicate Device: PulmoTrackTM model 1010 (k980878). Technological Characteristics Both the WIM-PCTM device and its predicate device (PulmoTrack TM; k980878) implement an… | 1998 |
| † | K042253 | Sleepsense Sleep Sensors | 2004 |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2007, 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 WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds.
The WIM-PCTM is indicated for use by or under the supervision of a physician while carrying out a provocation test, administering a bronchodilator or performing a physical examination in pulmonary function testing environment when there is a need for performing an acoustic pulmonary function measurement that quantifies the presence of wheezing. It is also indicated when there is a need to listen to amplified and filtered breath sounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071955: Wim-PC, Model 1010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071955
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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