# K221024: tremoflo C2 Airwave Oscillometry System

- Pathway: 510(k) (Traditional)
- Applicant: Thorasys Thoracic Medical Systems, Inc.
- Decided: Jun 20, 2023 after 440 days
- Product code: PNV (Impedance Measuring Device Utilizing Oscillation Techniques)
- Device class: 2
- Regulation: 21 CFR 868.1840
- 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 K954140 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170185: tremoFlo C-100 Airwave Oscillometry System, Thorasys Thoracic Medical Systems, Inc. (2017) Summary page 4.

## Indications for use
The tremoflo C2 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). The tremoflo C2 Airwave Oscillometry System is intended for use with pediatric and adult patients 4 years of age or older. The device is designed to be used by pulmonologists, general practitioners, nurses, respiratory therapists, laboratory technologists, medical researchers and similarly trained personnel in hospitals, clinics, and private physician offices.

Source page: https://510kreport.com/device/K221024
Methodology: https://510kreport.com/methodology