Cleared Traditional

K980979 - FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE

K980979 is an FDA 510(k) clearance for FUKUDA DENSHI MODEL HC-500 END TIDAL CO..., manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K980979

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.

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 239
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K980979.
MAGNATEK80
K983114 · Magna Advanced Technologies, Inc. · Sep 1998
MTEK-1400
K982846 · Magna Advanced Technologies, Inc. · Sep 1998
MICROCAP
K981114 · Oridion Medical , Ltd. · Jun 1998
VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER
K973544 · Vacumed, Div. of Vacumetrics, Inc. · May 1998
TRIP TONOMETRY CATHETER, 18F
K980384 · Datex-Engstrom, Inc. · May 1998
MICROSTREAM FILLERLINE OR/EMS
K980324 · Oridion Medical , Ltd. · Apr 1998