Cleared Traditional

K781746 - MINICO

K781746 is an FDA 510(k) clearance for MINICO, manufactured by Catalyst Research Corp.. The device is a Class 2 Anesthesiology device with product code CCJ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K781746 · Catalyst Research Corp. · Anesthesiology device
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Dec 1978
Decision
48d
Days
Class 2
Risk

K781746 is an FDA 510(k) clearance for the MINICO. Classified as Analyzer, Gas, Carbon-monoxide, Gaseous-phase (product code CCJ), Class II - Special Controls.

Submitted by Catalyst Research Corp. (Mchenry, US). The FDA issued a Cleared decision on December 5, 1978 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1430 - 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.

FDA 510(k) Submission Details - K781746

510(k) Number K781746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1978
Decision Date December 05, 1978
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 140d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCJ Device Classification - Class 2, Special Controls

Product Code CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1430
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 - CCJ Analyzer, Gas, Carbon-monoxide, Gaseous-phase

All 23
Devices cleared under the same product code (CCJ) and FDA review panel - the closest regulatory comparables to K781746.
ECOLYZER #200/COHB ANALYZER SYS
K832655 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1983
ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT
K802891 · Sherwood Medical Co. · Dec 1980
DIFFUSION OPTION, OMNI-LAB
K781871 · Ohio Medical Products · Jan 1979
DIFFUSION SYSTEM, SINGLE-BREATH (47404A)
K760169 · Hewlett-Packard Co. · Jul 1976
K781746 · MINICO
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