Skip to content

EasyOne Filter

by NDD Medizintechnik AG

510(k) K221250

EasyOne Filter is a medical device (FDA Class II; FDA product code CAH, Filter, Bacterial, Breathing-Circuit) made by NDD Medizintechnik AG, cleared under FDA 510(k) K221250 on 22 Nov 2022, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221250 Date22 Nov 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
CAH
Device class
Class II
Regulation
21 CFR Part 868.5260
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K221250

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K221250
UDI-DISize and differences
EasyOne Filter FT 2091-422
NDD Medizintechnik AG
2091-42207640142190899 —On the market
EasyOne Filter SP 2091-412
NDD Medizintechnik AG
2091-41207640142190882 —On the market

Similar devices

Other devices filed under FDA product code CAH (Filter, Bacterial, Breathing-Circuit).

Other devices from NDD Medizintechnik AG

See all devices from NDD Medizintechnik AG →