510(k) · Cleared
Recalled · Class II · 2017EasyOne Pro Respiratory Analysis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ndd Medizintechnik AG · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Feb 22, 2017 as substantially equivalent to K091428 (Ndd Medizitechnik AG, 2010) and 1 other predicate after a 264-day review. Its family tree reaches back 2 generations to 1994. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 22, 2017
- Review
- 264 days
- Class
- Class II
- Product code
- BTY
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K942211 (1994). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK942211 VMAX229 Series Pulmonary/Metabolic SystemsSensor Medics Corp. · 1994
- 1 generation backK091428 Easyone Pro Respiratory Analysis SystemNdd Medizitechnik AG · 2010
- This deviceK161534 EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG · 2017
- Descendant · cites it directly · 1 of its ownK221030 Model 9100 PFT/DICOVitalograph Ireland, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK223818 Model 9160 VitaloQUBVitalograph Ireland, Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942211 | VMAX229 Series Pulmonary/Metabolic Systems | Sensor Medics Corp. | 1994 | — |
| −1 | K091428 | Easyone Pro Respiratory Analysis System | Ndd Medizitechnik AG | 2010 | — |
| 0 (this device) | K161534 | EasyOne Pro Respiratory Analysis System | Ndd Medizintechnik AG | 2017 | — |
| +1 | K221030 | Model 9100 PFT/DICO | Vitalograph Ireland, Ltd. | 2022 | — |
| +2 | K223818 | Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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 BTY? 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 BTY device
- #1 K260242 CPETWise Platformscore 13.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K091428 | Easyone Pro Respiratory Analysis SystemSummary page 4…ator Product code: BTY Regulation number: 868.1890 Predicate Device Primary Predicate: EasyOne Pro Respiratory Analysis System, model EasyOne Pro K091428 Secondary Predicate: EasyOne Pro Respiratory Analysis System, model EasyOne Pro LAB K120635 Device Description The EasyOne Pro R… | 2010 |
| * | K120635 | Easyone Pro Respiratory Testing DeviceSummary page 4…Primary Predicate: EasyOne Pro Respiratory Analysis System, model EasyOne Pro K091428 Secondary Predicate: EasyOne Pro Respiratory Analysis System, model EasyOne Pro LAB K120635 Device Description The EasyOne Pro Respiratory Analysis System consists of two different device models: EasyOne Pro and EasyOne… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221030 | Model 9100 PFT/DICO | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2017 | Class II | Z-0596-2020 | Component change control | The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower electromagnetic shielding provided by the cable harness… |
| Aug 15, 2017 | Class II | Z-0597-2020 | Component change control | The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard. As a consequence of a lower electromagnetic shielding provided by the cable harness… |
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 15.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221030 (Vitalograph Ireland, Ltd., 2022) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BTY devicesBTY Calculator, Predicted Values, Pulmonary Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · BTY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BTY
266in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTY
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTY
5in 2024
MAUDE reports naming product code BTY, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 104 | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 3 | 139 | 0 | 2 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 1 | 1 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 24 |
| 2017 | 1 | — | 2 | 9 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 3 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 3 | 266 | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
EasyOne Pro/LAB is designed for conducting lung function measurements in general or specialist practices or in hospitals.
EasyOne Pro/LAB can also be used in clinical settings in occupational medicine for performing lung function screenings or measurements.
EasyOne Pro/LAB is used to conduct lung function measurements on adults and children starting at age 4, except measurements of diffusing capacity of the lung based on CO (DLCO), which can be performed on adults and children starting at age 6.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161534: EasyOne Pro Respiratory Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161534
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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