Cleared Traditional

K221250 - EasyOne Filter

K221250 is an FDA 510(k) clearance for EasyOne Filter, manufactured by Ndd Medizintechnik AG. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K221250 · Ndd Medizintechnik AG · General Hospital
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Nov 2022
Decision
204d
Days
Class 2
Risk

K221250 is an FDA 510(k) clearance for the EasyOne Filter. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Ndd Medizintechnik AG (Zurich, CH). The FDA issued a Cleared decision on November 22, 2022 after a review of 204 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ndd Medizintechnik AG devices

FDA 510(k) Submission Details - K221250

510(k) Number K221250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2022
Decision Date November 22, 2022
Days to Decision 204 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 129d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 79
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K221250.
TNI Clear-Guard™ 3 angled breathing filter (1545020)
K223258 · Intersurgical , Ltd. · Jun 2023
Filter and HME/Filter
K221472 · Ningbo Huakun Medical Equipment Co., Ltd. · Feb 2023
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
K221836 · Dr?gerwerk AG & Co KGaA · Dec 2022
GGM Breathing Circuit Bacterial Filter
K210352 · Great Group Medical Co, Ltd. · Mar 2022
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
K211286 · Pall Corporation · Nov 2021
Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
K202459 · Pharma System AB · Sep 2021