# K130322: SPM-300

- Pathway: 510(k) (Traditional)
- Applicant: Bionet Co., Ltd.
- Decided: Nov 15, 2013 after 280 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 K944762 (1994). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971336: Caird Technology Spirometer, Caird Technology (1998) Summary page 1.
- K123896: CCS-200 Spirometer, Benson Medical Instruments Co. (2013). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K220535: Cardio10 (2022), 2 descendants of its own
- K231160: Cardio Q50, Cardio Q70 (2023), 0 descendants of its own
- K231150: Cardio P1 (2023), 0 descendants of its own

## Indications for use
The SPM-300 Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients in general practice, specialty physician, and hospital settings.

Source page: https://510kreport.com/device/K130322
Methodology: https://510kreport.com/methodology