Cleared Traditional

K241465 - Midas Flowmeter (FDA 510(k) Clearance)

Also includes:
eAVS

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

K241465 · Parker Hannifin Corporation · Anesthesiology device
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Sep 2024
Decision
119d
Days
Class 2
Risk

K241465 is an FDA 510(k) clearance for the Midas Flowmeter. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Parker Hannifin Corporation (Hatfield, US). The FDA issued a Cleared decision on September 19, 2024 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - 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. Standard predicate reliance. 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 Parker Hannifin Corporation devices

Submission Details

510(k) Number K241465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2024
Decision Date September 19, 2024
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 139d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5330
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 - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 54
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K241465.
F&P Optiflow Air/Oxygen Flow Source
K243917 · Fisher &Paykel Healthcare , Ltd. · Jul 2025
Maxtec MaxBlend2+p
K231895 · Maxtec, LLC · Dec 2023
FlowStar Analog Mixer Flowmeter
K230987 · Baldus Sedation GmbH & Co. KG · Sep 2023
FlowStar Touch Digital Mixer Flowmeter
K222794 · Baldus Sedation GmbH & Co. KG · Jul 2023
Quality Mix Blender, Oxymixer
K221494 · Dehas Medical Systems GmbH · Jan 2023
Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50
K202480 · Parker Hannifin · Apr 2021