Cleared Traditional

K241465 - Midas Flowmeter

Also marketed or referenced as:
eAVS

K241465 is an FDA 510(k) clearance for Midas Flowmeter, manufactured by Parker Hannifin Corporation. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K241465 · Parker Hannifin Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K241465

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
21d faster than avg
Panel avg: 140d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZR Device Classification - Class 2, Special Controls

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 22
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