Cleared Traditional

K050860 - GE DATEX-OHMEDA CENTIVA/5 VENTILATOR

K050860 is an FDA 510(k) clearance for GE DATEX-OHMEDA CENTIVA/5 VENTILATOR, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K050860 · Datex-Ohmeda, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
77d
Days
Class 2
Risk

K050860 is an FDA 510(k) clearance for the GE DATEX-OHMEDA CENTIVA/5 VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on June 21, 2005 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K050860

510(k) Number K050860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2005
Decision Date June 21, 2005
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K050860.
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
K053388 · Puritan Bennett Corp. · Apr 2006
RAPHAEL COLOR
K052863 · Hamilton Medical AG · Jan 2006
GE DATEX-OHMEDA ENGSTROM CARESTATION
K051895 · Datex-Ohmeda, Inc. · Sep 2005
GE DATEX-OHMEDA ENGSTROM CARESTATION
K050597 · Datex-Ohmeda, Inc. · Mar 2005
GE DATEX-OHMEDA ENGSTROM CARESTATION
K041775 · Datex-Ohmeda, Inc. · Oct 2004
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
K041524 · Datex-Ohmeda, Inc. · Sep 2004