# K071955: Wim-PC, Model 1010

- Pathway: 510(k) (Special)
- Applicant: Karmelsonix
- Decided: Nov 1, 2007 after 108 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: 1 generation back to K980878 (1998). 1 ancestor in all.
17 later devices descend from it; 3 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980878: Pulmotrack,Model 1010, Karmel Medical Acoustic Technologies, Ltd. (1998) Summary page 2.

## Most influential descendants
- K090863: Personal Wheezometer (2009), 8 descendants of its own
- K131285: Sonosentry (2014), 7 descendants of its own
- K202062: wheezo WheezeRate Detector (2021), 6 descendants of its own
- K101022: Pulmotrack 5050 Wholter, Model 5050 (2010), 6 descendants of its own
- K221614: TytoCare Lung Sounds Analyzer (2023), 5 descendants of its own

## Indications for use
The WIM-PCTM is intended for the analysis, interpretation and documentation of lung sounds. The WIM-PCTM 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.

Source page: https://510kreport.com/device/K071955
Methodology: https://510kreport.com/methodology