# K042758: Polytech Pulmonary Function Filter

- Pathway: 510(k) (Traditional)
- Applicant: Polytechnic Resources, Inc.
- Decided: Aug 29, 2005 after 329 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 Polytech filter is a disposable, single-patient session filter for spirometric and pulmonary fuiction testing. The Polytech filter is designed to reduce cross contamination in pulmonary function equipment. The filter is to be used with children and adult subjects, but it is not indicated for use with neonatal subjects. It is to be used under the direction of a physician.

Source page: https://510kreport.com/device/K042758
Methodology: https://510kreport.com/methodology