# K111587: Alerkan Spirometry Filter

- Pathway: 510(k) (Traditional)
- Applicant: Alerkan, Ltd.
- Decided: Oct 20, 2011 after 135 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
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, single session, and disposable. Maximum duration of use is 24 hrs. Adaptable for use with the following PFT equipment: Model 9502: Approx. 30 mm ID × 34 mm OD; fits Viasys, SensorMedics, Jeager. Model 9503: Approx. 26.5 mm ID × 30 mm OD; fits MIR, Zan, nSpire, Micro Medical, Datospir. Model 9504: Approx. 45 mm ID × 48.5 mm; fits Koko Spirometer, KoKo Legend, and Koko Trek. Model 9505: Approx. 30 mm ID × 34 mm OD and approx. 26.5 mm ID × 30 mm OD; fits Viasys, SensorMedics, Jeager, MIR, Zan, nSpire, Micro Medical, Datospir. Environment of Use -- Hospital, Sub-acute Institutions, Doctor's offices, Laboratories Target Patient Populations: Adults

Source page: https://510kreport.com/device/K111587
Methodology: https://510kreport.com/methodology