Cleared Special

K041430 - BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000

K041430 is an FDA 510(k) clearance for BLEASE SIRIUS ANESTHESIA SYSTEM, manufactured by Blease Medical Equipment , Ltd.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 132-day FDA review.

K041430 · Blease Medical Equipment , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
132d
Days
Class 2
Risk

K041430 is an FDA 510(k) clearance for the BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Blease Medical Equipment , Ltd. (Appollo Beach, US). The FDA issued a Cleared decision on October 7, 2004 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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. Standard predicate reliance. 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 - K041430

510(k) Number K041430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2004
Decision Date October 07, 2004
Days to Decision 132 days
Submission Type Special
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
8d faster than avg
Panel avg: 140d · This submission: 132d
Pathway characteristics
Modification to existing cleared device.

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 158
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K041430.
GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM
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MALLARD MODEL 3000 ANESTHESIA MACHINE
K033026 · Mallard Medical, Inc. · Sep 2004
FABIUS GS ANESTHESIA SYSTEM
K042086 · Draeger Medical, Inc. · Aug 2004
GE DATEX-OHMEDA AISYS CARESTATION
K042154 · Datex-Ohmeda, Inc. · Aug 2004