510(k) · Cleared
ClearedAstraguard Pulmonary Function Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sdi Diagnostics, Inc. · BZG Spirometer, Diagnostic
Cleared on Jan 26, 2007 as substantially equivalent to K934509 (Sdi Diagnostics, Inc., 1993) and 2 other predicates after a 121-day review. Its family tree reaches back 3 generations to 1979.
- Decided
- Jan 26, 2007
- Review
- 121 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K792097 (1979). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK792097 Dryden Bacteria FilterDryden Corp. · 1979
- 2 generations backK961914 Bacteria/Viral FilterHudson Respiratory Care, Inc. · 1996
- 1 generation backK043148 All Flow Pulmonary Function FilterAlliance Tech Medical, Inc. · 2004 · Recalled
- This deviceK062913 Astraguard Pulmonary Function FilterSdi Diagnostics, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792097 | Dryden Bacteria Filter | Dryden Corp. | 1979 | — |
| −2 | K961914 | Bacteria/Viral Filter | Hudson Respiratory Care, Inc. | 1996 | — |
| −1 | K043148 | All Flow Pulmonary Function Filter | Alliance Tech Medical, Inc. | 2004 | 1 |
| 0 (this device) | K062913 | Astraguard Pulmonary Function Filter | Sdi Diagnostics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
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 BZG? 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 BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…21 CFR 868.5260 Classification Panel: Anesthesiology Regulatory Class: 11 Product Code: CAH Predicate Devices 510(k) #K934509 SDI Pulmoguard Filter 510(k) #K043148 Alliance Tech Medical All Flow Filter… | 1993 |
| * | K043148 | All Flow Pulmonary Function FilterSummary page 1…ulatory Class: 11 Product Code: CAH Predicate Devices 510(k) #K934509 SDI Pulmoguard Filter 510(k) #K043148 Alliance Tech Medical All Flow Filter 510(k) # K934475 Koko Disposable PFT Filter II Device Descrip… | 2004 |
| * | K934475 | Koko Filter IISummary page 1…510(k) #K934509 SDI Pulmoguard Filter 510(k) #K043148 Alliance Tech Medical All Flow Filter 510(k) # K934475 Koko Disposable PFT Filter II Device Description: The SDI AstraGuard Pulmonary Function Filter is an… | 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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 2 other devices also cite its predicate K934509.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, 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 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The AstraGuard Pulmonary Function Filter is intended to for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary testing instruments, associated valves and hoses, from aerosols and particulates, which may be present ina patient's exhaled gas. The device is indicated for diagnostic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062913: Astraguard Pulmonary Function Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062913
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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