Cleared Traditional

K062793 - SERVO-I VENTILATOR SYSTEM

Also marketed or referenced as:
NAVA OPTION

K062793 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 Traditional 510(k) pathway after a 142-day FDA review.

K062793 · Maquet Critical Care AB · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
142d
Days
Class 2
Risk

K062793 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 (Bridgewater, US). The FDA issued a Cleared decision on February 7, 2007 after a review of 142 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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

FDA 510(k) Submission Details - K062793

510(k) Number K062793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2006
Decision Date February 07, 2007
Days to Decision 142 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
2d slower than avg
Panel avg: 140d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K062793.
RAPHAEL COLOR ASV VENTILATOR
K071194 · Hamilton Medical AG · Oct 2007
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K063806 · Sleepnet Corporation · May 2007
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
K063650 · Puritan Bennett Corp. · Feb 2007
GE DATEX-OHMEDA ENGSTROM CARESTATION
K062710 · Datex-Ohmeda, Inc. · Dec 2006
NEWPORT E500 WAVE VENTILATOR
K061094 · Newport Medical Instruments, Inc. · Jul 2006
GALILEO GOLD ASV
K061090 · Hamilton Medical AG · Jul 2006