# K980878: Pulmotrack,Model 1010

- Pathway: 510(k) (Traditional)
- Applicant: Karmel Medical Acoustic Technologies, Ltd.
- Decided: Dec 28, 1998 after 294 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
No predicates in its family tree.
19 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Littmann Brand Electronic Stethoscope: named in the summary without a submission number
- (no number) Pulmonary Function Test Laboratory, System1010: named in the summary without a submission number

## Most influential descendants
- K071955: Wim-PC, Model 1010 (2007), 17 descendants of its own
- K012387: STG Multichannel Lung Sound Analysis System (2002), 9 descendants of its own
- 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

## Indications for use
The PulmoTrack Model 1010 is intended for the analysis, interpretation and documentation of lung sounds. The PulmoTrack Model 1010 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 a pulmonary function testing environment when there is a need to perform 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/K980878
Methodology: https://510kreport.com/methodology