# K093174: Spiropalm

- Pathway: 510(k) (Traditional)
- Applicant: Cosmed Srl
- Decided: Feb 26, 2010 after 141 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The COSMED Spiropaim and Spiropalm Plus pulmonary function testing system are spirometers for performing the basic lung function tests (basic spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and Pulse Oximetry tests on population from 4-6 years old to older population in the physician’s office or a hospital setting.

Source page: https://510kreport.com/device/K093174
Methodology: https://510kreport.com/methodology