Cleared Traditional

K980979 - FUKUDA DENSHI MODEL HC-500 END TIDAL CO...

K980979 is the FDA 510(k) clearance for FUKUDA DENSHI MODEL HC-500 END TIDAL CO... by Fukuda Denshi USA, Inc.. It is a Class 2 Anesthesiology device (product code CCK) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K980979 · Fukuda Denshi USA, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
87d
Days
Class 2
Risk

K980979 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on June 12, 1998 after a review of 87 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. 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 Fukuda Denshi USA, Inc. devices

Submission Details

510(k) Number K980979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1998
Decision Date June 12, 1998
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
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 134
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K980979.
ETCO2 VITAL SIGNS MODULE
K983864 · Mennen Medical, Inc. · Oct 1999
NONIN PULSE OXIMETER AND CARBON DIOXIDE DETECTOR, MODELS 9843, 9845 AND 9847
K982969 · Nonin Medical, Inc. · Aug 1999
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
TIDAL WAVE CARBON DIOXIDE MONITOR, MODEL 610
K963327 · Novametrix Medical Systems, Inc. · Nov 1996
DISPOSABLE GAS SAMPLING INTERFACE KITS
K960972 · Marquest Medical Products, Inc. · Oct 1996