Cleared Traditional

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

Also includes:
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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Regulatory Context
Review time vs. panel average
288d slower than avg
Panel avg: 139d · 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 Peers - CBK Ventilator, Continuous, Facility Use

All 503
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K180098.
Inbentus Versatile
K252663 · Iconic Solutions by Murcia, SL · Apr 2026
VPAP Pediatric Face Mask
K251888 · Hsiner Co., Ltd. · Mar 2026
Vivo 45 LS
K232365 · Oconnell Regulatory Consultants, Inc. · Dec 2025
F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A)
K252173 · Fisher &Paykel Healthcare , Ltd. · Sep 2025
SV600, SV800 Ventilator
K243767 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Aug 2025
AVEA disposable expiratory filter/water trap (11790)
K251133 · Telesair, Inc. · May 2025