# K103575: Spiro PD

- Pathway: 510(k) (Traditional)
- Applicant: Pmd Healthcare
- Decided: Nov 9, 2011 after 338 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 K901057 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031643: Spirotel, Model 29-1020, Sdi Diagnostics, Inc. (2003) Summary page 1.
- K073155: Vitalograph Model 4000 (Asma-1 and Copd-6), Vitalograph (Ireland), Ltd. (2008) Summary page 1.

## Indications for use
The SPIRO PD spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in child, adolescent and adult. It is also intended to be used as a single-patient device only and can be used in the home, factory, hospital or physician's office. The SPIRO PD spirometer is indicated for the following age groups: * 2-12 years - Child * 13-21 years - Adolescent * 22 and over- Adult

Source page: https://510kreport.com/device/K103575
Methodology: https://510kreport.com/methodology