# K072722: Meddorna Wireless PRN Spirometer 100

- Pathway: 510(k) (Traditional)
- Applicant: Meddorna, LLC
- Decided: Apr 24, 2008 after 211 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: 4 generations back to K963725 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973138: Spirocard, Qrs Diagnostic, LLC (1998) Summary page 1.
- K050853: PMP4 Spiropro, Card Guard Scientific Survival, Ltd. (2005) Summary page 1.

## Indications for use
The MEDDORNA Wireless PRN Spirometer Model 100 is intended for use as a diagnostic spirometer, measuring FVC, MW and SVC breathing functions.

Source page: https://510kreport.com/device/K072722
Methodology: https://510kreport.com/methodology