Cleared Special

BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 (K041430) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K041430 · Blease Medical Equipment , Ltd. · Anesthesiology device
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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

Submission Details

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.

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 K041430.
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