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Minico

by Catalyst Research Corp.

510(k) K781746

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781746 Date5 Dec 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CCJ
Device Class
Class II
Regulation
21 CFR Part 868.1430
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Minico is a carbon monoxide gas analyzer designed for the gaseous phase. It functions as a medical device used to measure and monitor carbon monoxide levels.

This device is regulated under FDA 510(k) clearance K781746. It is classified as a class 2 medical device under regulation number 868.1430 within the anesthesiology specialty.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Minico device?

    The Minico is a specialized medical device engineered to measure and monitor carbon monoxide levels specifically within the gaseous phase.

  • How is the Minico classified for regulatory purposes?

    The Minico is classified as a class 2 medical device under regulation number 868.1430 within the anesthesiology specialty and holds FDA 510(k) clearance K781746.

  • Which medical specialty is this analyzer associated with?

    The device is categorized under the anesthesiology specialty, as indicated by its regulation number 868.1430 and its review by the anesthesiology advisory committee.