510(k) · Cleared
ClearedMir Spirobank Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mir Medical Intl. Research Srl · BZG Spirometer, Diagnostic
Cleared on Dec 21, 1998 after a 48-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 41 later devices descend from it.
- Decided
- Dec 21, 1998
- Review
- 48 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 2 citing it directly.
- This deviceK983909 Mir Spirobank SpirometerMir Medical Intl. Research Srl · 1998
- Descendant · cites it directly · 40 of its ownK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- Descendant · cites it directly · 33 of its ownK072979 Spirobank GMir Medical Intl. Research Srl · 2007
- Descendant · 2 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- Descendant · 3 generations on · 8 of its ownK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
- Descendant · 3 generations on · 7 of its ownK221282 Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K061712Spirobank IIMir Medical Intl. Research Srl · 2006 · cites it directly40descendants
- K072979Spirobank GMir Medical Intl. Research Srl · 2007 · cites it directly33descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 2 generations on16descendants
- K210133Current Health Monitoring System Gen 2 (G2)Current Health · 2021 · 3 generations on8descendants
- K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983909 | Mir Spirobank Spirometer | Mir Medical Intl. Research Srl | 1998 | — |
| +1 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| +1 | K072979 | Spirobank G | Mir Medical Intl. Research Srl | 2007 | — |
| +2 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
| +3 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | — |
| +3 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 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? (41)
See all 412 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, K061712 (Mir Medical Intl. Research Srl, 2006) has gone furthest, with 40 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?
Device is a spirometer for lung-function testing.
For testing lung-function in people from children to adults, generally used by a physician or by a respiratory therapist or technician.
Device is portable and thus can be used at home, in the factory, in the hospital, in the doctor's office.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983909 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983909: Mir Spirobank Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983909
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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