# K092813: Astrasonic Spirometer, Model 29-8000

- Pathway: 510(k) (Traditional)
- Applicant: Sdi Diagnostics, Inc.
- Decided: Jul 16, 2010 after 305 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: 2 generations back to K944762 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993921: NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model 2001, Ndd Medical Technologies (2000) Summary page 1.

## Most influential descendants
- K150137: SpiroThor (2015), 0 descendants of its own

## Indications for use
The SDI AstraSonic Spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical and hospital settings.

Source page: https://510kreport.com/device/K092813
Methodology: https://510kreport.com/methodology