Cleared Traditional

K801599 - CORNING 184 BLOOD GAS TONOMETER

K801599 is an FDA 510(k) clearance for CORNING 184 BLOOD GAS TONOMETER, manufactured by Corning Medical & Scientific. The device is a Class 1 Chemistry device with product code LCH cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K801599 · Corning Medical & Scientific · Chemistry device
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Aug 1980
Decision
37d
Days
Class 1
Risk

K801599 is an FDA 510(k) clearance for the CORNING 184 BLOOD GAS TONOMETER. Classified as Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical (product code LCH), Class I - General Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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.

FDA 510(k) Submission Details - K801599

510(k) Number K801599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1980
Decision Date August 20, 1980
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 89d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

LCH Device Classification - Class 1, General Controls

Product Code LCH Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LCH Tonometer (calibration And Q.c. Of Blood-gas Instruments), Clinical

All 8
Devices cleared under the same product code (LCH) and FDA review panel - the closest regulatory comparables to K801599.
AMR RESEARCH TONOMETER
K862958 · Associated Medical Representatives · Nov 1986
LINEAR CLOUD TONOMETER
K841089 · Linear Tonometers, Inc. · May 1984
HEM-O-SCAN OXYGEN EQUIL. CURVE ANALYZER
K802379 · American Instrument Co. · Oct 1980
PRECISION GAS MIXER
K781417 · Medicor USA , Ltd. · Sep 1978
EBS 775 TONOMETER
K781386 · Equilibrated Bio Systems, Inc. · Sep 1978
K801599 · CORNING 184 BLOOD GAS TONOMETER
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