510(k) · Cleared
ClearedPulmotrack 2020 System
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 Mar 4, 2011 as substantially equivalent to K071955 (Karmelsonix, 2007) and 1 other predicate after a 207-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Mar 4, 2011
- Review
- 207 days
- Class
- Class II
- Product code
- BZM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K891104 (1989). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK891104 CD Telemetry SystemsMarquette Electronics, Inc. · 1989
- 3 generations backK974149 Ambulatory X-12 Telemetry ModuleMortara Instrument, Inc. · 1998 · Recalled
- 2 generations backK030795 Lifesyne SystemsGmp/Companies, Inc. · 2003 · Recalled
- 1 generation backK090610 Hospira Vital Signs Wireless Monitoring SystemHospira, Inc. · 2009
- This deviceK102229 Pulmotrack 2020 SystemKarmelsonix · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K891104 | CD Telemetry Systems | Marquette Electronics, Inc. | 1989 | — |
| −3 | K974149 | Ambulatory X-12 Telemetry Module | Mortara Instrument, Inc. | 1998 | 1 |
| −2 | K030795 | Lifesyne Systems | Gmp/Companies, Inc. | 2003 | 3 |
| −1 | K090610 | Hospira Vital Signs Wireless Monitoring System | Hospira, Inc. | 2009 | — |
| 0 (this device) | K102229 | Pulmotrack 2020 System | Karmelsonix | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 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 2…Incorporates the same intended use and the same technology as the PilmoTrack"l 2010 (W1M-PC"), cleared in K071955 1-4 Pidmo Trackr' 2020 - Special Sl0kNotiflcation === Page 3 ==… | 2007 |
| * | K090610 | Hospira Vital Signs Wireless Monitoring SystemSummary page 3…*The Bluetooth is substantial equivalence to HOSPIRA Vital Signs Wireless Monitoring System, cleared in K090610 Performance Validation: The PulmoTrlckT"I 2020 underwent validation testing to ensure pe… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 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. 2011, 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 PulmoTrack 2020 is intended for the analysis, interpretation and documentation of lung sounds.
The PulmoTrack 2020 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.
The PulmoTrack 2020 is indicated for patient population above two years old
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102229: Pulmotrack 2020 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102229
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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