Cleared Abbreviated

K102182 - MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30 (FDA 510(k) Clearance)

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

K102182 · Maquet Critical Care AB · Anesthesiology device
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May 2011
Decision
279d
Days
Class 2
Risk

K102182 is an FDA 510(k) clearance for the MAQUET FLOW-I C20, MAQUET FLOW-I C30, MODEL 66 77 200, 66 77 30. 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 May 9, 2011 after a review of 279 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 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 Maquet Critical Care AB devices

Submission Details

510(k) Number K102182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2010
Decision Date May 09, 2011
Days to Decision 279 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 139d · This submission: 279d
Pathway characteristics
Standards-based clearance path.

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 186
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