510(k) · Cleared
ClearedASTRA 300
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 31, 2007 as substantially equivalent to K013812 (Sdi Diagnostics, Inc., 2002) and 1 other predicate after a 239-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Jan 31, 2007
- Review
- 239 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K981533 (1998). 8 ancestors in all, the oldest K963678 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK981533 Aviva Systems Model Numbers 1010, 2020American Telecare, Inc. · 1998
- 3 generations backK012801 N2000 Base Station, N2001 Nurse StationNeptec Design Group, Ltd. · 2001
- 2 generations backK020584 N2000 Base Station; N2001 Nurse StationNeptec Design Group, Ltd. · 2002
- 1 generation backK031863 Carestation 126S VideophoneMotion Media Technology, Inc. · 2003
- This deviceK061571 ASTRA 300Sdi Diagnostics, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981533 | Aviva Systems Model Numbers 1010, 2020 | American Telecare, Inc. | 1998 | — |
| −3 | K012801 | N2000 Base Station, N2001 Nurse Station | Neptec Design Group, Ltd. | 2001 | — |
| −2 | K020584 | N2000 Base Station; N2001 Nurse Station | Neptec Design Group, Ltd. | 2002 | — |
| −1 | K031863 | Carestation 126S Videophone | Motion Media Technology, Inc. | 2003 | — |
| 0 (this device) | K061571 | ASTRA 300 | Sdi Diagnostics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 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? (2)
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 |
|---|---|---|---|
| * | K013812 | Spirolab II, Model 29Summary page 1…868.1840 Classification Panel: Anesthesiology Regulatory Class: II Product Code: BZG, DQA Predicate Devices 510(k) #K013812 80I Spirolab II Spirometer 510(k) #K031863 Motion Media Technology CareStation 126S Device Descript… | 2002 |
| * | K031863 | Carestation 126S VideophoneSummary page 1…ass: II Product Code: BZG, DQA Predicate Devices 510(k) #K013812 80I Spirolab II Spirometer 510(k) #K031863 Motion Media Technology CareStation 126S Device Description: The ASTRA 300 Diagnostic Spirometer is a hand-held portabl… | 2003 |
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 9 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K013812.
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 SDI Astra 300 Spirometer is a freestanding laboratory instrument for performing basic lung function tests and oximetry in people of all ages. It is intended to be used by physicians or professional medical personnel for testing in any setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061571 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061571: ASTRA 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061571
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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