# K980662: Lichen, Bacterial in Line Breathing Filter

- Pathway: 510(k) (Traditional)
- Applicant: Dhd Healthcare Corp.
- Decided: Sep 14, 1998 after 206 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: 1 generation back to K934509 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934509: Pulmoguard Disposable Baterial/Viral Filter, Sdi Diagnostics, Inc. (1993) Summary page 1.

## Indications for use
1 - Purpose/Claims: The DHD Healthcare Lichen Filter Kit is intended to filter airborne particulate matter and certain bacteria (i.e., Staphylococcus) with a mean diameter of 3.2 microns or greater. The Lichen may reduce cross-contamination between patient and equipment attachments such as use with Respiratory Therapy low flow pressure indicators and gauges (i.e., an example would be for use with the DHD TheraPEP® Pressure Indicator and aneroid gauges). The use of the Lichen Filter Kit may allow the re-use of aneroid gauges and pressure indicators from patient to patient per your institution’s protocol. The device also incorporates tubing for use in connection to low flow pressure indicators and gauges. Caution Statement: Follow the recommended cleaning frequency and infection control procedures included in the gauge or pressure indicator’s original labeling when used with the Lichen filter. Do not alter your institution’s standard infection control procedures for equipment reuse. 2 - Target Patient Population: Patients requiring the use of low flow pressure indicators and gauges in respiratory therapy as determined by professional medical personnel. The DHD Lichen Filter is recommended for use with the DHD TheraPEP® Pressure Indicator and aneroid gauges. 3 - Intended Environment For Use 4.1 Labeling reflects the statement: “Federal (USA) Law restricts this device to sale by or on the order of a physician.” 4.2 Hospital or home after a period of training.

Source page: https://510kreport.com/device/K980662
Methodology: https://510kreport.com/methodology