510(k) · Cleared
ClearedPulmoguard Disposable Baterial/Viral Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sdi Diagnostics, Inc. · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Oct 21, 1993 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 21, 1993
- Review
- 37 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK934509 Pulmoguard Disposable Baterial/Viral FilterSdi Diagnostics, Inc. · 1993
- Descendant · cites it directly · 0 of its ownK062913 Astraguard Pulmonary Function FilterSdi Diagnostics, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK050424 Ergofilter Spi Accessory to Spirolyser SPL-50Fim Medical · 2005
- Descendant · cites it directly · 0 of its ownK980662 Lichen, Bacterial in Line Breathing FilterDhd Healthcare Corp. · 1998
Most influential descendants
Showing 3 of 3 · See all- K062913Astraguard Pulmonary Function FilterSdi Diagnostics, Inc. · 2007 · cites it directly0descendants
- K050424Ergofilter Spi Accessory to Spirolyser SPL-50Fim Medical · 2005 · cites it directly0descendants
- K980662Lichen, Bacterial in Line Breathing FilterDhd Healthcare Corp. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K934509 | Pulmoguard Disposable Baterial/Viral Filter | Sdi Diagnostics, Inc. | 1993 | — |
| +1 | K062913 | Astraguard Pulmonary Function Filter | Sdi Diagnostics, Inc. | 2007 | — |
| +1 | K050424 | Ergofilter Spi Accessory to Spirolyser SPL-50 | Fim Medical | 2005 | — |
| +1 | K980662 | Lichen, Bacterial in Line Breathing Filter | Dhd Healthcare Corp. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K062913 (Sdi Diagnostics, Inc., 2007) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K934509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K934509: Pulmoguard Disposable Baterial/Viral Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934509
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026