510(k) · Cleared
ClearedEasyOne Sky Spirometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ndd Medizintechnik AG · BZG Spirometer, Diagnostic
Cleared on Oct 19, 2023 as substantially equivalent to K161536 (Ndd Medizintechnik AG, 2017) after a 269-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Oct 19, 2023
- Review
- 269 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944762 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK944762 Puritan-Bennett Renaissance Spirometry Systemwith the…Puritan Bennett Corp. · 1994
- 2 generations backK993921 NDD Medical Technologies Easyone Spirometer: Frontline Model 2000…Ndd Medical Technologies · 2000
- 1 generation backK161536 EasyOne Air SpirometerNdd Medizintechnik AG · 2017
- This deviceK230178 EasyOne Sky SpirometerNdd Medizintechnik AG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB… | Puritan Bennett Corp. | 1994 | — |
| −2 | K993921 | NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and… | Ndd Medical Technologies | 2000 | — |
| −1 | K161536 | EasyOne Air Spirometer | Ndd Medizintechnik AG | 2017 | — |
| 0 (this device) | K230178 | EasyOne Sky Spirometer | Ndd Medizintechnik AG | 2023 | — |
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 |
|---|---|---|---|
| * | K161536 | EasyOne Air SpirometerSummary page 6…egulatory class: Class II Product Code: BZG PREDICATE DEVICE Primary Predicate Device: EasyOne Air Spirometer, K161536 Reference Devices: GoSpiro, K163249, K202837 INDICATIONS FOR USE The EasyOne Sky spirometer is intended to co… | 2017 |
| † | K163249 | GoSpiro | 2017 |
| † | K202837 | GoSpiro | 2020 |
| † | K221250 | EasyOne Filter | 2022 |
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 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 3 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 EasyOne Sky spirometer is intended to conduct diagnostic spirometry testing on adults and pediatric patients starting at age 4.
The EasyOne Sky spirometer is used by general practitioners, specialists and healthcare professionals.
The EasyOne Sky is used in hospitals, clinics, pharmacies, in clinical settings, and in occupational medicine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230178 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230178: EasyOne Sky Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230178
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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