Cleared Traditional

MicroTrend System

K212425 · Exostat Medical, Inc. · Anesthesiology

Nov 2024

Decision

1191d

Days

Class 2

Risk

About This 510(k) Submission

K212425 is an FDA 510(k) clearance for the MicroTrend System, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Exostat Medical, Inc. (Prior Lake, US). The FDA issued a Cleared decision on November 7, 2024, 1191 days after receiving the submission on August 4, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number	K212425 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 04, 2021
Decision Date	November 07, 2024
Days to Decision	1191 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF