Cleared Special

K040221 - SERVO-I VENTILATOR SYSTEM

K040221 is an FDA 510(k) clearance for SERVO-I VENTILATOR SYSTEM, manufactured by Maquet Critical Care AB. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Special 510(k) pathway after a 18-day FDA review.

K040221 · Maquet Critical Care AB · Anesthesiology device
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Feb 2004
Decision
18d
Days
Class 2
Risk

K040221 is an FDA 510(k) clearance for the SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Maquet Critical Care AB (Iselin, US). The FDA issued a Cleared decision on February 20, 2004 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Maquet Critical Care AB devices

FDA 510(k) Submission Details - K040221

510(k) Number K040221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2004
Decision Date February 20, 2004
Days to Decision 18 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

CBK Device Classification - Class 2, Special Controls

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 273
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K040221.
GE DATEX-OHMEDA ENGSTROM CARESTATION
K041775 · Datex-Ohmeda, Inc. · Oct 2004
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
K041524 · Datex-Ohmeda, Inc. · Sep 2004
BIRD TBIRD VELA VENTILATOR
K032451 · Bird Products Corp. · Mar 2004
NEWPORT E500 WAVE VENTILATOR
K030780 · Newport Medical Instruments, Inc. · Jan 2004
ESPRIT VENTILATOR, MODEL V1000
K034040 · Respironics, Inc. · Jan 2004
RAPHAEL
K022679 · Hamilton Medical AG · Oct 2003