# K062913: Astraguard Pulmonary Function Filter

- Pathway: 510(k) (Traditional)
- Applicant: Sdi Diagnostics, Inc.
- Decided: Jan 26, 2007 after 121 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: 3 generations back to K792097 (1979). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934509: Pulmoguard Disposable Baterial/Viral Filter, Sdi Diagnostics, Inc. (1993) Summary page 1.
- K043148: All Flow Pulmonary Function Filter, Alliance Tech Medical, Inc. (2004) Summary page 1.
- K934475: Koko Filter II, Pulmonary Data Services Inst., Inc. (1993) Summary page 1.

## Indications for use
The AstraGuard Pulmonary Function Filter is intended to for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary testing instruments, associated valves and hoses, from aerosols and particulates, which may be present ina patient's exhaled gas. The device is indicated for diagnostic applications.

Source page: https://510kreport.com/device/K062913
Methodology: https://510kreport.com/methodology