Cleared Traditional

SERVO-U Ventilator System version 2.1 (K180098) - FDA 510(k) Clearance

Also marketed or referenced as:
SERVO-n Ventilator System version 2.1

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

K180098 · Maquet Critical Care AB · Anesthesiology device
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Mar 2019
Decision
427d
Days
Class 2
Risk

K180098 is an FDA 510(k) clearance for the SERVO-U Ventilator System version 2.1. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Maquet Critical Care AB (Solna, SE). The FDA issued a Cleared decision on March 19, 2019 after a review of 427 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Maquet Critical Care AB devices

Submission Details

510(k) Number K180098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2018
Decision Date March 19, 2019
Days to Decision 427 days
Submission Type Traditional
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
287d slower than avg
Panel avg: 140d · This submission: 427d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 Consultant

Maquet Medical System USA
Mark Dinger

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 79
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K180098.
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