# K013123: Ems Pulmonary Function Testing Filter

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Medical Systems
- Decided: Mar 14, 2002 after 176 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: 1 generation back to K934475 (1993). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934475: Koko Filter II, Pulmonary Data Services Inst., Inc. (1993) Summary page 1.

## Most influential descendants
- K051712: Model 2800 PFT Filter (2005), 1 descendant of its own
- K142303: NeumoFilt Ergo/Neumo Filt BiteOn (2014), 0 descendants of its own
- K083233: The PFT Filter (2009), 0 descendants of its own

## Indications for use
For use with pulmonary function testing. To filter air between the patient’s exhaled air and the testing equipment. Single patient use.

Source page: https://510kreport.com/device/K013123
Methodology: https://510kreport.com/methodology