# K033939: Flosense II, Model 29-8040

- Pathway: 510(k) (Traditional)
- Applicant: Sdi Diagnostics, Inc.
- Decided: Jan 30, 2004 after 46 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Flosense II is intended to be used as a disposable pneumotach for the Puritan-Bennett Renaissance II Spirometers which currently use the Puritan Bennett FSII Flow Sensor.

Source page: https://510kreport.com/device/K033939
Methodology: https://510kreport.com/methodology