# K163249: GoSpiro

- Pathway: 510(k) (Traditional)
- Applicant: Monitored Therapeutics, Inc.
- Decided: Mar 24, 2017 after 126 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: 5 generations back to K943404 (1994). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072979: Spirobank G, Mir Medical Intl. Research Srl (2007) Summary page 4.

## Most influential descendants
- K213754: SpiroHome Personal, SpiroHome Clinic (2023), 0 descendants of its own
- K202837: GoSpiro (2020), 0 descendants of its own

## Indications for use
The GoSpiro® is intended to be used by adults and children over 5 years old in physician’s offices, clinics and home settings to conduct basic lung function and spirometry testing. It is a single-patient use device.

Source page: https://510kreport.com/device/K163249
Methodology: https://510kreport.com/methodology