Cleared Special

K052167 - DATEX-OHMEDA S/5 TONOMETRY MODULE

K052167 is an FDA 510(k) clearance for DATEX-OHMEDA S/5 TONOMETRY MODULE, manufactured by Ge Healthcare. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Special 510(k) pathway after a 30-day FDA review.

K052167 · Ge Healthcare · Anesthesiology device
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Sep 2005
Decision
30d
Days
Class 2
Risk

K052167 is an FDA 510(k) clearance for the DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Ge Healthcare (Needham, US). The FDA issued a Cleared decision on September 8, 2005 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Ge Healthcare devices

FDA 510(k) Submission Details - K052167

510(k) Number K052167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2005
Decision Date September 08, 2005
Days to Decision 30 days
Submission Type Special
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
110d faster than avg
Panel avg: 140d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 152
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K052167.
CARBON DIOXIDE MONITOR, MODEL OLG-2800A
K062115 · Nihon Kohden America, Inc. · Dec 2006
DATEX-OHMEDA S/5 INTERFACE MODULE E-INT
K052880 · Ge Healthcare · Nov 2005
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES
K052582 · Ge Healthcare · Oct 2005
C-CO2 COLORIMETRIC CO2 INDICATOR
K050066 · Marquest Medical Products, Inc. · Mar 2005
CAP-ONE, MODEL TG-920P
K040875 · Nihon Kohden America, Inc. · Oct 2004
MODIFICATION TO VAMOS ANESTHETIC GAS MONITOR
K040847 · Draeger Medical, Inc. · Jun 2004