# K102229: Pulmotrack 2020 System

- Pathway: 510(k) (Special)
- Applicant: Karmelsonix
- Decided: Mar 4, 2011 after 207 days
- Product code: BZM (Calculator, Pulmonary Function Interpretor (Diagnostic))
- Device class: 2
- Regulation: 21 CFR 868.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K891104 (1989). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071955: Wim-PC, Model 1010, Karmelsonix (2007) Summary page 2.
- K090610: Hospira Vital Signs Wireless Monitoring System, Hospira, Inc. (2009) Summary page 3.

## Indications for use
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

Source page: https://510kreport.com/device/K102229
Methodology: https://510kreport.com/methodology