510(k) · Cleared
ClearedEasyOne Air 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 Jan 5, 2017 as substantially equivalent to K993921 (Ndd Medical Technologies, 2000) after a 216-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jan 5, 2017
- Review
- 216 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944762 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK944762 Puritan-Bennett Renaissance Spirometry Systemwith the…Puritan Bennett Corp. · 1994
- 1 generation backK993921 NDD Medical Technologies Easyone Spirometer: Frontline Model 2000…Ndd Medical Technologies · 2000
- This deviceK161536 EasyOne Air SpirometerNdd Medizintechnik AG · 2017
- Descendant · cites it directly · 0 of its ownK230178 EasyOne Sky SpirometerNdd Medizintechnik AG · 2023
Most influential descendants
Showing 1 of 1 · See all- K230178EasyOne Sky SpirometerNdd Medizintechnik AG · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB… | Puritan Bennett Corp. | 1994 | — |
| −1 | K993921 | NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and… | Ndd Medical Technologies | 2000 | — |
| 0 (this device) | K161536 | EasyOne Air Spirometer | Ndd Medizintechnik AG | 2017 | — |
| +1 | K230178 | EasyOne Sky Spirometer | Ndd Medizintechnik AG | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K993921 | NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model…Summary page 4…BZG Regulation number: 868.1840 Predicate device: Substantial equivalence is claimed to the ndd EasyOne Spirometer, cleared for commercial distribution per K993921. Device Description: The ndd EasyOne Air is a diagnostic spirometer. In order to conduct simple diagnostic spirometry testing,… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230178 | EasyOne Sky Spirometer | 2023 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 16.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K230178 (Ndd Medizintechnik AG, 2023) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K993921.
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Air spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients over 4 years old. The EasyOne Air spirometer is used by general practitioners, specialists, and health care professionals, in hospitals and clinics, in pharmacies, and in clinical settings in occupational medicine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161536 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161536: EasyOne Air Spirometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161536
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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