510(k) · Cleared
ClearedAlveoair Digital Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roundworks Technologies Private Limited · BZG Spirometer, Diagnostic
Cleared on Aug 28, 2023 as substantially equivalent to K183089 (Nuvoair AB, 2020) after a 371-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Aug 28, 2023
- Review
- 371 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K943404 (1994). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK943404 3301 Pulse OximeterBci Intl., Inc. · 1994
- 5 generations backK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- 4 generations backK043528 SpirotelMir Medical Intl. Research Srl · 2005
- 3 generations backK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- 2 generations backK072979 Spirobank GMir Medical Intl. Research Srl · 2007
- 1 generation backK183089 Air NextNuvoair AB · 2020
- This deviceK222525 Alveoair Digital SpirometerRoundworks Technologies Private Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943404 | 3301 Pulse Oximeter | Bci Intl., Inc. | 1994 | — |
| −5 | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| −4 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| −3 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| −2 | K072979 | Spirobank G | Mir Medical Intl. Research Srl | 2007 | — |
| −1 | K183089 | Air Next | Nuvoair AB | 2020 | — |
| 0 (this device) | K222525 | Alveoair Digital Spirometer | Roundworks Technologies Private Limited | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2003 | 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? (1)
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 |
|---|---|---|---|
| * | K183089 | Air NextSummary page 4…FR 868.1840 Review Panel: Anesthesiology Device Class: Class II Product Code: BZG Predicate Device: Air Next (K183089) Reference device: Spirobank G (K072979) Device Description The alveoair Digital Spirometer is used to test lung fun… | 2020 |
| † | K072979 | Spirobank G | 2007 |
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 29 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 11 ancestors has a recall.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 alveoair Digital Spirometer is intended to conduct basic lung function and spirometry testing on patients aged ≥ 22
years by healthcare professionals or clinicians in any healthcare environment. The use of an alveoair Digital Spirometer is
not intended for use during patient transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222525: Alveoair Digital Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222525
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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