Cleared Traditional

K110594 - GF-210R MULTI-GAS MODULE FOR NOHON KOHD...

K110594 is an FDA 510(k) clearance for GF-210R MULTI-GAS MODULE FOR NOHON KOHD..., manufactured by Nihon Kohden Corp.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K110594 · Nihon Kohden Corp. · Anesthesiology device
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Oct 2011
Decision
240d
Days
Class 2
Risk

K110594 is an FDA 510(k) clearance for the GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Nihon Kohden Corp. (Foothill, US). The FDA issued a Cleared decision on October 28, 2011 after a review of 240 days - an extended review cycle.

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. 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 Nihon Kohden Corp. devices

FDA 510(k) Submission Details - K110594

510(k) Number K110594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2011
Decision Date October 28, 2011
Days to Decision 240 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
100d slower than avg
Panel avg: 140d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

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