Cleared Traditional

K980367 - AEROSET SYSTEM

K980367 is an FDA 510(k) clearance for AEROSET SYSTEM, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CGZ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K980367 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
62d
Days
Class 2
Risk

K980367 is an FDA 510(k) clearance for the AEROSET SYSTEM. Classified as Electrode, Ion-specific, Chloride (product code CGZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on April 1, 1998 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - the FDA in vitro diagnostics and chemistry 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K980367

510(k) Number K980367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1998
Decision Date April 01, 1998
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGZ Device Classification - Class 2, Special Controls

Product Code CGZ Electrode, Ion-specific, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGZ Electrode, Ion-specific, Chloride

All 24
Devices cleared under the same product code (CGZ) and FDA review panel - the closest regulatory comparables to K980367.
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
K060108 · Roche Diagnostics Corp. · Feb 2006
EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZER
K000926 · Medica Corp. · May 2000
ILAB 600 CLINICAL CHEMISTRY SYSTEM
K980757 · Instrumentation Laboratory CO · Apr 1998
ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS
K972004 · Alko Diagnostic Corp. · Jun 1997
SYNERMED ISE REAGENTS
K962479 · Synermed, Inc. · Mar 1997
CAPILLARY ADAPTOR ACCESSORY
K963992 · Medica Corp. · Nov 1996