Cleared Traditional

K033026 - MALLARD MODEL 3000 ANESTHESIA MACHINE

K033026 is an FDA 510(k) clearance for MALLARD MODEL 3000 ANESTHESIA MACHINE, manufactured by Mallard Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K033026 · Mallard Medical, Inc. · Anesthesiology device
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Sep 2004
Decision
343d
Days
Class 2
Risk

K033026 is an FDA 510(k) clearance for the MALLARD MODEL 3000 ANESTHESIA MACHINE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Mallard Medical, Inc. (Redding, US). The FDA issued a Cleared decision on September 3, 2004 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Mallard Medical, Inc. devices

FDA 510(k) Submission Details - K033026

510(k) Number K033026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date September 03, 2004
Days to Decision 343 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
203d slower than avg
Panel avg: 140d · This submission: 343d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 115
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K033026.
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
K050055 · Datex-Ohmeda, Inc. · Feb 2005
PRIMUS US
K042607 · Draeger Medical, Inc. · Nov 2004
FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM
K042419 · Draeger Medical, Inc. · Oct 2004
FABIUS GS ANESTHESIA SYSTEM
K042086 · Draeger Medical, Inc. · Aug 2004
GE DATEX-OHMEDA AISYS CARESTATION
K042154 · Datex-Ohmeda, Inc. · Aug 2004
MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM
K041622 · Draeger Medical, Inc. · Jul 2004