510(k) · Cleared
ClearedSpirotel, Model 29-1020
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 Dec 9, 2003 after a 196-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 44 later devices descend from it.
- Decided
- Dec 9, 2003
- Review
- 196 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
44 later devices descend from it, 2 citing it directly.
- This deviceK031643 Spirotel, Model 29-1020Sdi Diagnostics, Inc. · 2003
- Descendant · cites it directly · 42 of its ownK043528 SpirotelMir Medical Intl. Research Srl · 2005
- Descendant · 2 generations on · 40 of its ownK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- Descendant · 3 generations on · 33 of its ownK072979 Spirobank GMir Medical Intl. Research Srl · 2007
- Descendant · 4 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- Descendant · 5 generations on · 8 of its ownK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
Showing 5 of 44 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 44 · See all- K043528SpirotelMir Medical Intl. Research Srl · 2005 · cites it directly42descendants
- K061712Spirobank IIMir Medical Intl. Research Srl · 2006 · 2 generations on40descendants
- K072979Spirobank GMir Medical Intl. Research Srl · 2007 · 3 generations on33descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 4 generations on16descendants
- K210133Current Health Monitoring System Gen 2 (G2)Current Health · 2021 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031643 | Spirotel, Model 29-1020 | Sdi Diagnostics, Inc. | 2003 | — |
| +1 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| +2 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| +3 | K072979 | Spirobank G | Mir Medical Intl. Research Srl | 2007 | — |
| +4 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
| +5 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (44)
See all 442 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, K043528 (Mir Medical Intl. Research Srl, 2005) has gone furthest, with 42 descendants of its own.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 spirotel spirometer is intended to be used by a patient under the instruction of a physician or respiratory therapist to test lung function in people of all ages. It is also intended to be used as a single-patient device only and can be used in any setting - home, factory, hospital or physician's office.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031643: Spirotel, Model 29-1020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031643
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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