510(k) · Cleared
ClearedEasyOne Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ndd Medizintechnik AG · CAH Filter, Bacterial, Breathing-Circuit
Cleared on Nov 22, 2022 as substantially equivalent to K000654 (A-M Systems, Inc., 2000) after a 204-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Nov 22, 2022
- Review
- 204 days
- Class
- Class II
- Product code
- CAH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000654 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000654 VBMAXA-M Systems, Inc. · 2000
- This deviceK221250 EasyOne FilterNdd Medizintechnik AG · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000654 | VBMAX | A-M Systems, Inc. | 2000 | — |
| 0 (this device) | K221250 | EasyOne Filter | Ndd Medizintechnik AG | 2022 | — |
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 CAH? 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 CAH device
- #1 K251583 Ambu® Virobac II® Exhalation Filterscore 11.6 · 2 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 |
|---|---|---|---|
| * | K000654 | VBMAXSummary page 5…CAH PREDICATE DEVICE Subject Device: EasyOne Filter Primary Predicate Device: VBmax Viral and Bacterial Filter, K000654 Reference Devices: Air Safety Model 2800 PFT Filter, K051712 Easy-On PC… | 2000 |
| † | K051712 | Model 2800 PFT Filter | 2005 |
| † | K090034 | Easy on-PC Spirometer | 2009 |
| † | K161536 | EasyOne Air Spirometer | 2017 |
| † | K063526 | A-M Systems Viromax Viral and Bacterial Filter | 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?
- Its one ancestor has no recall.
How does its category compare?
All CAH devicesCAH Filter, Bacterial, Breathing-Circuit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · CAH
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAH
237in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAH
1in 2025
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · CAH
77in 2025
MAUDE reports naming product code CAH, 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 | 32 |
| 2008 | 1 | — | 0 | 27 |
| 2009 | 4 | 111 | 0 | 18 |
| 2010 | 5 | 216 | 2 | 40 |
| 2011 | 3 | 281 | 0 | 9 |
| 2012 | 3 | 212 | 0 | 16 |
| 2013 | 1 | — | 1 | 47 |
| 2014 | 4 | 250 | 1 | 98 |
| 2015 | 2 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 34 |
| 2017 | 1 | — | 1 | 29 |
| 2018 | 0 | — | 0 | 33 |
| 2019 | 2 | — | 0 | 30 |
| 2020 | 2 | — | 0 | 33 |
| 2021 | 2 | — | 0 | 56 |
| 2022 | 3 | 204 | 6 (6) | 67 |
| 2023 | 3 | 237 | 0 | 40 |
| 2024 | 2 | — | 0 | 51 |
| 2025 | 0 | — | 1 (1) | 77 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The EasyOne Filter is intended to be used in combination with NDD breathing mouthpieces to reduce bacteria, viruses and other particulates from the patient's exhaled air while performing flow measurements, such as spirometry tests. The EasyOne Filter is a single-use device and intended for single-patient use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221250 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221250: EasyOne Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221250
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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