510(k) · Cleared
ClearedSTG Multichannel Lung Sound Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stethographics, Inc. · BZM Calculator, Pulmonary Function Interpretor (Diagnostic)
Cleared on Apr 23, 2002 as substantially equivalent to K980878 (Karmel Medical Acoustic Technologies, Ltd., 1998) after a 270-day review. Its family tree reaches back 1 generation to 1998. 9 later devices descend from it.
- Decided
- Apr 23, 2002
- Review
- 270 days
- Class
- Class II
- Product code
- BZM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980878 (1998). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK980878 Pulmotrack,Model 1010Karmel Medical Acoustic Technologies, Ltd. · 1998
- This deviceK012387 STG Multichannel Lung Sound Analysis SystemStethographics, Inc. · 2002
- 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 · 4 generations on · 5 of its ownK221614 TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023
- Descendant · 5 generations on · 4 of its ownK232237 Tyto Insights for Wheeze DetectionTyto Care, Ltd. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K090863Personal WheezometerKarmelsonix · 2009 · cites it directly8descendants
- K131285SonosentryIsonea, Ltd. · 2014 · 2 generations on7descendants
- K202062wheezo WheezeRate DetectorRespiri Limited · 2021 · 3 generations on6descendants
- K221614TytoCare Lung Sounds AnalyzerTyto Care, Ltd. · 2023 · 4 generations on5descendants
- K232237Tyto Insights for Wheeze DetectionTyto Care, Ltd. · 2023 · 5 generations on4descendants
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) | K012387 | STG Multichannel Lung Sound Analysis System | Stethographics, Inc. | 2002 | — |
| +1 | K090863 | Personal Wheezometer | Karmelsonix | 2009 | — |
| +2 | K131285 | Sonosentry | Isonea, Ltd. | 2014 | — |
| +3 | K202062 | wheezo WheezeRate Detector | Respiri Limited | 2021 | — |
| +4 | K221614 | TytoCare Lung Sounds Analyzer | Tyto Care, Ltd. | 2023 | — |
| +5 | K232237 | Tyto Insights for Wheeze Detection | Tyto Care, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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 1010 Our OCR of the scanned summary read K980978, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Pulmotrack, Model 1010”. | 1998 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090863 | Personal Wheezometer | 2009 | 8 |
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.
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 Stethographics STG Multichannel Lung Sound Analysis system is intended for the recording, audio reproduction, graphic display and automated identification of lung sounds. It can be configured to record from one or more than one channel.
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/K012387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012387: STG Multichannel Lung Sound Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012387
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026