Cleared Traditional

Evita V800, Evita V600 (K222024) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222024 · Draegerwerk AG & CO Kgaa · Anesthesiology device
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May 2023
Decision
309d
Days
Class 2
Risk

K222024 is an FDA 510(k) clearance for the Evita V800, Evita V600. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Draegerwerk AG & CO Kgaa (Luebeck, DE). The FDA issued a Cleared decision on May 16, 2023 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Draegerwerk AG & CO Kgaa devices

Submission Details

510(k) Number K222024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2022
Decision Date May 16, 2023
Days to Decision 309 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
169d slower than avg
Panel avg: 140d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 73
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K222024.
Panther 5
K213098 · Origin Medical Devices · Jul 2023
Mindray SV600 Ventilator, Mindray SV800 Ventilator
K220107 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2023
Nihon Kohden NKV-440 Ventilator System
K222644 · Nihon Kohden Orangemed, Inc. · May 2023
Babylog VN800, Babylog VN600
K222207 · Draegerwerk AG & CO Kgaa · May 2023
LTV2 Series Ventilators
K201082 · Vyaire Medical, Inc. · Nov 2021
CARESCAPE R860
K210384 · Datex-Ohmeda, Inc. · Nov 2021