Cleared Special

K051629 - BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 158
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