# K042058: Oneflow FVC, Oneflow FVC (Kit), Oneflow FVC Screen

- Pathway: 510(k) (Traditional)
- Applicant: Clement Clarke Intl., Ltd.
- Decided: Mar 23, 2005 after 236 days
- Product code: BZG (Spirometer, Diagnostic)
- 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: 1 generation back to K895953 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895953: Wright Ventilometer VM-1, Clement Clarke, Inc. (1990) Summary page 1.

## Indications for use
The OneFlow FVC is a handheld, battery operated, electronic Spirometer intended to measure the maximal volume and flow of air that can be moved through a patient's lungs. The device is intended for use with pediatric and adult patients in a variety of clinical settings. Additional models include the OneFlow FVC (kit), which contains software that can statistically analyze data on a PC; and the OneFlow FVC Screen, which displays the gathered data in comparison with stored predicted values.

Source page: https://510kreport.com/device/K042058
Methodology: https://510kreport.com/methodology