# K230501: Spirobank Oxi

- Pathway: 510(k) (Traditional)
- Applicant: Mir Medical International Research USA
- Decided: Dec 15, 2023 after 294 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)
- K103530: Spirodoc, Medical International Research USA, Inc. (2011) Summary page 4.

## Indications for use
The Spirobank Oxi Spirometer and Pulse Oximeter is intended to be used by a physician or by a patient under the prescribed use of a physician. The equipment is intended to test lung function and can perform tests in adult and pediatric patients greater than 5 years. When used as Oximeter, the Spirobank Oxi is intended for spot-checking of functional oxygen saturation of arterial haemoglobin (SpO2) and Pulse Rate (PR) from the patient finger . The Spirobank Oxi has been designed for use in the physician’s office, in hospital, or directly by the patient to monitor her/his physical conditions at home.

Source page: https://510kreport.com/device/K230501
Methodology: https://510kreport.com/methodology