Cleared Traditional

ETCO2 VITAL SIGNS MODULE (K983864) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K983864 · Mennen Medical, Inc. · Anesthesiology device
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Oct 1999
Decision
340d
Days
Class 2
Risk

K983864 is an FDA 510(k) clearance for the ETCO2 VITAL SIGNS MODULE. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Mennen Medical, Inc. (Rehovot, IL). The FDA issued a Cleared decision on October 8, 1999 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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. Elevated predicate reliance profile. 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 Mennen Medical, Inc. devices

Submission Details

510(k) Number K983864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1998
Decision Date October 08, 1999
Days to Decision 340 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
201d slower than avg
Panel avg: 139d · This submission: 340d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 59
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K983864.
MULTIGAS UNIT, MODEL AG-920RA
K020046 · Nihon Kohden America, Inc. · Jul 2002
INFINITY ETCO2 + RESPIRATORY MECHANICS POD
K003550 · Siemens Medical Solutions USA, Inc. · Mar 2001
SIEMEMNS INFINITY ETC02 POD
K992116 · Siemens Medical Solutions USA, Inc. · Jan 2000
NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES
K990063 · Nihon Kohden America, Inc. · Jun 1999
NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES
K964305 · Nihon Kohden America, Inc. · Feb 1997
SIEMENS SC 9000 ETCO2 MODULE
K954632 · Siemens Medical Solutions USA, Inc. · Feb 1996