Cleared Traditional

K112114 - MAQUET FLOW-I C20

K112114 is an FDA 510(k) clearance for MAQUET FLOW-I C20, manufactured by Maquet Critical Care AB. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K112114 · Maquet Critical Care AB · Anesthesiology device
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Jan 2012
Decision
172d
Days
Class 2
Risk

K112114 is an FDA 510(k) clearance for the MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Maquet Critical Care AB (Wayne, US). The FDA issued a Cleared decision on January 13, 2012 after a review of 172 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Maquet Critical Care AB devices

FDA 510(k) Submission Details - K112114

510(k) Number K112114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2011
Decision Date January 13, 2012
Days to Decision 172 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 140d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 111
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