Cleared Special

K041430 - BLEASE SIRIUS ANESTHESIA SYSTEM

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)
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.

View all Blease Medical Equipment , Ltd. devices

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
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 115
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
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