Cleared Traditional

K001609 - MALLARD AIR OXYGEN ACCUBLENDER (FDA 510(k) Clearance)

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

K001609 · Mallard Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
78d
Days
Class 2
Risk

K001609 is an FDA 510(k) clearance for the MALLARD AIR OXYGEN ACCUBLENDER. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Mallard Medical, Inc. (Redding, US). The FDA issued a Cleared decision on August 10, 2000 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mallard Medical, Inc. devices

Submission Details

510(k) Number K001609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2000
Decision Date August 10, 2000
Days to Decision 78 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
61d faster than avg
Panel avg: 139d · This submission: 78d
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 K001609.
F&P Optiflow Air/Oxygen Flow Source
K243917 · Fisher &Paykel Healthcare , Ltd. · Jul 2025
Midas Flowmeter
K241465 · Parker Hannifin Corporation · Sep 2024
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