# K051712: Model 2800 PFT Filter

- Pathway: 510(k) (Traditional)
- Applicant: Air Safety, Ltd.
- Decided: Sep 1, 2005 after 66 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K142303: NeumoFilt Ergo/Neumo Filt BiteOn (2014), 0 descendants of its own

## Indications for use
Model 2800 is indicated for use with pulmonary function testing equipment, to filter air between the patient's exhaled air and the testing equipment. Single patient use

Source page: https://510kreport.com/device/K051712
Methodology: https://510kreport.com/methodology