510(k) · Cleared
ClearedEasyone Pro Respiratory Testing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ndd Medizitechnik AG · BTY Calculator, Predicted Values, Pulmonary Function
Cleared on Sep 27, 2012 as substantially equivalent to K942211 (Sensor Medics Corp., 1994) after a 210-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Sep 27, 2012
- Review
- 210 days
- Class
- Class II
- Product code
- BTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K942211 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK942211 VMAX229 Series Pulmonary/Metabolic SystemsSensor Medics Corp. · 1994
- This deviceK120635 Easyone Pro Respiratory Testing DeviceNdd Medizitechnik AG · 2012
- Descendant · cites it directly · 2 of its ownK161534 EasyOne Pro Respiratory Analysis SystemNdd Medizintechnik AG · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK221030 Model 9100 PFT/DICOVitalograph Ireland, Ltd. · 2022
- Descendant · 3 generations on · 0 of its ownK223818 Model 9160 VitaloQUBVitalograph Ireland, Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942211 | VMAX229 Series Pulmonary/Metabolic Systems | Sensor Medics Corp. | 1994 | — |
| 0 (this device) | K120635 | Easyone Pro Respiratory Testing Device | Ndd Medizitechnik AG | 2012 | — |
| +1 | K161534 | EasyOne Pro Respiratory Analysis System | Ndd Medizintechnik AG | 2017 | 2 |
| +2 | K221030 | Model 9100 PFT/DICO | Vitalograph Ireland, Ltd. | 2022 | — |
| +3 | K223818 | Model 9160 VitaloQUB | Vitalograph Ireland, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K942211 | VMAX229 Series Pulmonary/Metabolic SystemsSummary page 1…ction Product code: BTY Predicate Device: Substantial Equivalence is claimed with the SensorMedics Vmax 229 Series Pulmonary Function Analysis Instrument, K942211. The ndd Medical Technologies EasyOne Pro Respiratory System consists of two different device models: EasyOne Pro and EasyOne Pro… | 1994 |
| † | K091428 | Easyone Pro Respiratory Analysis System | 2010 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161534 | EasyOne Pro Respiratory Analysis System | 2017 | 2 |
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?
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. 2012, 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?
The ndd EasyOne Pro Respiratory Analysis System is designed for conducting lung function
measurements in general or specialist practices or in hospitals. The EasyOne Pro Respiratory
Analysis System can also be used outside of the laboratory when performing lung function
screenings or measurements in occupational medicine.
The EasyOne Pro Respiratory Analysis System 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/K120635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120635: Easyone Pro Respiratory Testing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120635
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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