Cleared Traditional

K191027 - Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191027 · Maquet Critical Care AB · Anesthesiology device
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Mar 2020
Decision
335d
Days
Class 2
Risk

K191027 is an FDA 510(k) clearance for the Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System. 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 18, 2020 after a review of 335 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 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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K191027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2019
Decision Date March 18, 2020
Days to Decision 335 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
196d slower than avg
Panel avg: 139d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K191027.
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K201957 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2021