# K090863: Personal Wheezometer

- Pathway: 510(k) (Traditional)
- Applicant: Karmelsonix
- Decided: Sep 21, 2009 after 175 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: 2 generations back to K980878 (1998). 3 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 12 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 1.
- K012387: STG Multichannel Lung Sound Analysis System, Stethographics, Inc. (2002)

## Most influential descendants
- K131285: Sonosentry (2014), 7 descendants of its own
- K202062: wheezo WheezeRate Detector (2021), 6 descendants of its own
- K221614: TytoCare Lung Sounds Analyzer (2023), 5 descendants of its own
- K232237: Tyto Insights for Wheeze Detection (2023), 4 descendants of its own
- K240555: Tyto Insights for Crackles Detection (2024), 1 descendant of its own

## Indications for use
The PERSONAL WHEEZOMETERTM is intended for quantifying the presence of wheezing. This device should be used under the direction of a physician or licensed healthcare professional for monitoring acoustic pulmonary functions.

Source page: https://510kreport.com/device/K090863
Methodology: https://510kreport.com/methodology