# K061571: ASTRA 300

- Pathway: 510(k) (Traditional)
- Applicant: Sdi Diagnostics, Inc.
- Decided: Jan 31, 2007 after 239 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: 4 generations back to K981533 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013812: Spirolab II, Model 29, Sdi Diagnostics, Inc. (2002) Summary page 1.
- K031863: Carestation 126S Videophone, Motion Media Technology, Inc. (2003) Summary page 1.

## Indications for use
The SDI Astra 300 Spirometer is a freestanding laboratory instrument for performing basic lung function tests and oximetry in people of all ages. It is intended to be used by physicians or professional medical personnel for testing in any setting.

Source page: https://510kreport.com/device/K061571
Methodology: https://510kreport.com/methodology