Cleared Abbreviated

K123211 - A5 ANESTHESIA DELIVERY SYSTEM

K123211 is an FDA 510(k) clearance for A5 ANESTHESIA DELIVERY SYSTEM, manufactured by Datascope Corp., Patient Monitoring Division. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Abbreviated 510(k) pathway after a 125-day FDA review.

K123211 · Datascope Corp., Patient Monitoring Division · Anesthesiology device
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Feb 2013
Decision
125d
Days
Class 2
Risk

K123211 is an FDA 510(k) clearance for the A5 ANESTHESIA DELIVERY SYSTEM. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Datascope Corp., Patient Monitoring Division (Mahwh, US). The FDA issued a Cleared decision on February 14, 2013 after a review of 125 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Datascope Corp., Patient Monitoring Division devices

FDA 510(k) Submission Details - K123211

510(k) Number K123211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2012
Decision Date February 14, 2013
Days to Decision 125 days
Submission Type Abbreviated
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
15d faster than avg
Panel avg: 140d · This submission: 125d
Pathway characteristics
Standards-based clearance path.

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 130
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