# K213754: SpiroHome Personal, SpiroHome Clinic

- Pathway: 510(k) (Traditional)
- Applicant: Inofab Saglik Teknolojileri A.S
- Decided: Jun 12, 2023 after 559 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: 6 generations back to K943404 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163249: GoSpiro, Monitored Therapeutics, Inc. (2017) Summary page 4.

## Indications for use
SpiroHome is intended to be used by adults and children over 5 years old in physician's offices, clinics and home setting to conduct basic lung function and spirometry testing.

Source page: https://510kreport.com/device/K213754
Methodology: https://510kreport.com/methodology