# K170185: tremoFlo C-100 Airwave Oscillometry System

- Pathway: 510(k) (Traditional)
- Applicant: Thorasys Thoracic Medical Systems, Inc.
- Decided: Sep 12, 2017 after 232 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: 3 generations back to K954140 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152585: Resmon PRO FULL, Medical Graphics Corp. (2016) Summary page 4.

## Most influential descendants
- K221024: tremoflo C2 Airwave Oscillometry System (2023), 0 descendants of its own

## Indications for use
The tremoFlo C-100 Airwave Oscillometry System is intended to measure respiratory system impedance using the Forced Oscillation Technique (FOT). tremoFlo C-100 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/K170185
Methodology: https://510kreport.com/methodology