Cleared Special

K990293 - ALADDIN II MONITORING OXYGEN/AIR MONITOR

K990293 is an FDA 510(k) clearance for ALADDIN II MONITORING OXYGEN/AIR MONITOR, manufactured by Hamilton Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Special 510(k) pathway after a 46-day FDA review.

K990293 · Hamilton Medical, Inc. · Anesthesiology device
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Mar 1999
Decision
46d
Days
Class 2
Risk

K990293 is an FDA 510(k) clearance for the ALADDIN II MONITORING OXYGEN/AIR MONITOR. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Hamilton Medical, Inc. (Snellville, US). The FDA issued a Cleared decision on March 16, 1999 after a review of 46 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K990293

510(k) Number K990293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1999
Decision Date March 16, 1999
Days to Decision 46 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
Pathway characteristics
Modification to existing cleared device.

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 47
Devices cleared under the same product code (BZR) and FDA review panel - the closest regulatory comparables to K990293.
SK MED M201 MIXER
K022864 · Sk Med · Apr 2003
MALLARD AIR OXYGEN ACCUBLENDER
K001609 · Mallard Medical, Inc. · Aug 2000
SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES
K992503 · Sechrist Industries, Inc. · Aug 1999
BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
K973646 · Bird Products Corp. · May 1998
AIR OXYGE MIXER
K974372 · Sk Med · Feb 1998
ALADDIN MONITORING OXYGEN/AIR MIXER
K960359 · Hamilton Medical, Inc. · Apr 1996