# K201002: Safey Pocket Spirometer

- Pathway: 510(k) (Traditional)
- Applicant: Safey Medical Devices Pvt, Ltd.
- Decided: Jul 30, 2020 after 105 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.
No later device cites it as a predicate yet.
0 of 11 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 5.

## Indications for use
Safey Pocket Spirometer is a spirometer intended to be used by a patient under the instruction of a physician to perform basic lung function and spirometry testing for users above 5 years of age in home healthcare environment.

Source page: https://510kreport.com/device/K201002
Methodology: https://510kreport.com/methodology