510(k) · Cleared
ClearedPulmotrack,Model 1010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karmel Medical Acoustic Technologies, Ltd. · BZM Calculator, Pulmonary Function Interpretor (Diagnostic)
Cleared on Dec 28, 1998 after a 294-day review. The FDA summary names its predicate without a number. 19 later devices descend from it.
- Decided
- Dec 28, 1998
- Review
- 294 days
- Class
- Class II
- Product code
- BZM
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 2 citing it directly.
- This deviceK980878 Pulmotrack,Model 1010Karmel Medical Acoustic Technologies, Ltd. · 1998
- Descendant · cites it directly · 17 of its ownK071955 Wim-PC, Model 1010Karmelsonix · 2007
- Descendant · cites it directly · 9 of its ownK012387 STG Multichannel Lung Sound Analysis SystemStethographics, Inc. · 2002
- Descendant · 2 generations on · 8 of its ownK090863 Personal WheezometerKarmelsonix · 2009
- Descendant · 3 generations on · 7 of its ownK131285 SonosentryIsonea, Ltd. · 2014
- Descendant · 4 generations on · 6 of its ownK202062 wheezo WheezeRate DetectorRespiri Limited · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K071955Wim-PC, Model 1010Karmelsonix · 2007 · cites it directly17descendants
- K012387STG Multichannel Lung Sound Analysis SystemStethographics, Inc. · 2002 · cites it directly9descendants
- K090863Personal WheezometerKarmelsonix · 2009 · 2 generations on8descendants
- K131285SonosentryIsonea, Ltd. · 2014 · 3 generations on7descendants
- K202062wheezo WheezeRate DetectorRespiri Limited · 2021 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980878 | Pulmotrack,Model 1010 | Karmel Medical Acoustic Technologies, Ltd. | 1998 | — |
| +1 | K071955 | Wim-PC, Model 1010 | Karmelsonix | 2007 | — |
| +1 | K012387 | STG Multichannel Lung Sound Analysis System | Stethographics, Inc. | 2002 | — |
| +2 | K090863 | Personal Wheezometer | Karmelsonix | 2009 | — |
| +3 | K131285 | Sonosentry | Isonea, Ltd. | 2014 | — |
| +4 | K202062 | wheezo WheezeRate Detector | Respiri Limited | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Littmann Brand Electronic Stethoscope Named without a submission number | |
| * | — | Pulmonary Function Test Laboratory, System1010 Named without a submission number |
What descends from it? (19)
See all 192 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?
- Of its descendants, K071955 (Karmelsonix, 2007) has gone furthest, with 17 descendants of its own.
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.
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 PulmoTrack Model 1010 is intended for the analysis, interpretation and documentation of lung sounds.
The PulmoTrack Model 1010 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 a pulmonary function testing environment when there is a need to perform 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980878: Pulmotrack,Model 1010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980878
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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