Cleared Traditional

MALLARD MODEL 3000 ANESTHESIA MACHINE (K033026) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 33
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K033026.
A7 Anesthesia System
K151954 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
A7 Anesthesia System
K142552 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2015
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
K083413 · Philips Medical Systems · Dec 2008
PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM SOFTWARE
K030939 · Philips Medical Systems · Jul 2003
KION ANESTHESIA SYSTEM
K973971 · Siemens Medical Solutions USA, Inc. · Sep 1999
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
K973896 · Ohmeda Medical · Apr 1998