Cleared Abbreviated

K160665 - FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 (FDA 510(k) Clearance)

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

K160665 · Maquet Critical Care AB · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Mar 2017
Decision
385d
Days
Class 2
Risk

K160665 is an FDA 510(k) clearance for the FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia.... Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Maquet Critical Care AB (Solna, SE). The FDA issued a Cleared decision on March 29, 2017 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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 K160665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2016
Decision Date March 29, 2017
Days to Decision 385 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
246d slower than avg
Panel avg: 139d · This submission: 385d
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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