# K221250: EasyOne Filter

- Pathway: 510(k) (Traditional)
- Applicant: Ndd Medizintechnik AG
- Decided: Nov 22, 2022 after 204 days
- Product code: CAH (Filter, Bacterial, Breathing-Circuit)
- Device class: 2
- Regulation: 21 CFR 868.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000654 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000654: VBMAX, A-M Systems, Inc. (2000) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K221250
Methodology: https://510kreport.com/methodology