# K133428: Medikro Nano, Medikro Primo and Medikro Pro

- Pathway: 510(k) (Traditional)
- Applicant: Medikro OY
- Decided: May 21, 2014 after 194 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: 2 generations back to K935732 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971336: Caird Technology Spirometer, Caird Technology (1998) Summary page 1.
- K052158: Welch Allyn Cardioperfect Workstation Version 1.5.0 Software, Welch Allyn, Inc. (2005) Summary page 1.

## Indications for use
Medikro®D Spironieter is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values. The device is designed to test pulmonary function and obtain spirometric indices for " adult and pediatric patients 12 years and older, * hospital and clinic use only.

Source page: https://510kreport.com/device/K133428
Methodology: https://510kreport.com/methodology