# K142303: NeumoFilt Ergo/Neumo Filt BiteOn

- Pathway: 510(k) (Traditional)
- Applicant: Medical Respiratory Devices S.L.
- Decided: Nov 20, 2014 after 94 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: 3 generations back to K934475 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051712: Model 2800 PFT Filter, Air Safety, Ltd. (2005) Summary page 5.

## Indications for use
For use with pulmonary function testing (PFT) equipment only, to filter air between the patient’s exhaled air and the testing equipment. Single patient use, disposable. Duration of use <24 hours. Environment of use: Hospital, Sub-acute facilities, Clinics, Physician offices. For use with pulmonary function testing (PFT) equipment only, to filter air between the patient’s exhaled air and the testing equipment. Single patient use, disposable. Duration of use <24 hours. Environment of use: Hospital, Sub-acute facilities, Clinics, Physician offices.

Source page: https://510kreport.com/device/K142303
Methodology: https://510kreport.com/methodology