510(k) · Cleared
ClearedLichen, Bacterial in Line Breathing Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dhd Healthcare Corp. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Sep 14, 1998 as substantially equivalent to K934509 (Sdi Diagnostics, Inc., 1993) after a 206-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Sep 14, 1998
- Review
- 206 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934509 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK934509 Pulmoguard Disposable Baterial/Viral FilterSdi Diagnostics, Inc. · 1993
- This deviceK980662 Lichen, Bacterial in Line Breathing FilterDhd Healthcare Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934509 | Pulmoguard Disposable Baterial/Viral Filter | Sdi Diagnostics, Inc. | 1993 | — |
| 0 (this device) | K980662 | Lichen, Bacterial in Line Breathing Filter | Dhd Healthcare Corp. | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K934509 | Pulmoguard Disposable Baterial/Viral FilterSummary page 1…Line Breathing Filter with Tubing (Ambient Air) . Classification name - Filter, Bacterial, Breathing-Circuit Predicate Device: Pulmoguard™ Bagcterial and Virus Filter (K934509) SDI Diagnostics 10 Hampden Drive, Easton, MA 02375 Device Description The DHD Lichen Product is a kit consisting of a hydroph… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K934509.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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).…
Read the full statement (225 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980662 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980662: Lichen, Bacterial in Line Breathing Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980662
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026