Cleared Special

K051629 - BLEAS ESIRIUC ANAESTHSIA SYSTEM

K051629 is an FDA 510(k) clearance for BLEAS ESIRIUC ANAESTHSIA SYSTEM, manufactured by Blease USA, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 95-day FDA review.

K051629 · Blease USA, Inc. · Anesthesiology device
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Sep 2005
Decision
95d
Days
Class 2
Risk

K051629 is an FDA 510(k) clearance for the BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Blease USA, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on September 23, 2005 after a review of 95 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 USA, Inc. devices

FDA 510(k) Submission Details - K051629

510(k) Number K051629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2005
Decision Date September 23, 2005
Days to Decision 95 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
45d faster than avg
Panel avg: 140d · This submission: 95d
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
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