Cleared Traditional

K983114 - MAGNATEK80

K983114 is an FDA 510(k) clearance for MAGNATEK80, manufactured by Magna Advanced Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K983114 · Magna Advanced Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
18d
Days
Class 2
Risk

K983114 is an FDA 510(k) clearance for the MAGNATEK80. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Magna Advanced Technologies, Inc. (Miami, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 18 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 Magna Advanced Technologies, Inc. devices

FDA 510(k) Submission Details - K983114

510(k) Number K983114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1998
Decision Date September 22, 1998
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
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 222
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K983114.
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
CAPNOCHECK II, MODEL 8400
K991086 · Bci Intl., Inc. · Jun 1999
MTEK-1400
K982846 · Magna Advanced Technologies, Inc. · Sep 1998
MICROCAP
K981114 · Oridion Medical , Ltd. · Jun 1998
FUKUDA DENSHI MODEL HC-500 END TIDAL CO2 MODULE
K980979 · Fukuda Denshi USA, Inc. · Jun 1998