# K251777: MESI mTABLET SPIRO

- Pathway: 510(k) (Traditional)
- Applicant: Mesi D.O.O.
- Decided: Mar 2, 2026 after 265 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: 8 generations back to K896120 (1990). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212938: Vitalograph Model 6000 Alpha, Vitalograph Ireland, Ltd. (2022) Summary page 5.

## Indications for use
The MESI mTABLET SPIRO is indicated for use to conduct assessment of respiratory function by way of measurement of dynamic lung volumes (also known as spirometry) on adult and pediatric patients, ages 5 years and older. The device measures patient respiratory parameters including FVC, FEV1, FEV6, and VC. MESI mTABLET SPIRO is intended to be operated by medical professionals in health care environments including primary care facilities, hospitals and health centers.

Source page: https://510kreport.com/device/K251777
Methodology: https://510kreport.com/methodology