# K043148: All Flow Pulmonary Function Filter

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Tech Medical, Inc.
- Decided: Dec 13, 2004 after 28 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K792097 (1979). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961914: Bacteria/Viral Filter, Hudson Respiratory Care, Inc. (1996) 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.

## Most influential descendants
- K121382: Westmed, Inc.'S Blockaide Filter [21 CFR 807.87(a)] (2012), 0 descendants of its own
- K062913: Astraguard Pulmonary Function Filter (2007), 0 descendants of its own

## Recalls of this device
- Oct 6, 2014 · Class II · Z-0714-2020: Patients have experienced a bad taste associated with the filters.

## Indications for use
The Alliance Tech Medical, Inc. All Flow Pulmonary Function 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/K043148
Methodology: https://510kreport.com/methodology