# K083233: The PFT Filter

- Pathway: 510(k) (Traditional)
- Applicant: Pulmonary Filtration Technologies, LLC
- Decided: Mar 2, 2009 after 119 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 K934475 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013123: Ems Pulmonary Function Testing Filter, Engineered Medical Systems (2002) Summary page 2.
- K934475: Koko Filter II, Pulmonary Data Services Inst., Inc. (1993) Summary page 1.

## Indications for use
For use with pulmonary function'testing. To filter air between the patients's exhaled air and the testing equipment. Single patient use, single session, disposable.

Source page: https://510kreport.com/device/K083233
Methodology: https://510kreport.com/methodology