# K121382: Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)]

- Pathway: 510(k) (Traditional)
- Applicant: Westmed, Inc.
- Decided: Dec 6, 2012 after 212 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- 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 K792097 (1979). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043148: All Flow Pulmonary Function Filter, Alliance Tech Medical, Inc. (2004) Summary page 2.
- K973314: Spirosafe Filter, Micro Direct, Inc. (1997) Summary page 2.
- K934475: Koko Filter II, Pulmonary Data Services Inst., Inc. (1993) Summary page 2.
- K934272: Sensormedics Microgard Microbial Filter, Sensor Medics Corp. (1993) Summary page 2.
- K951410: Disposable Pulmonary Function Filter, Creative Biomedics, Inc. (1995) Summary page 2.

## Indications for use
The Westmed, Inc. BlockAide Filter is designed as a disposable and single-use, bi-directional filter for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary function testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.

Source page: https://510kreport.com/device/K121382
Methodology: https://510kreport.com/methodology