Cleared Traditional

Medical Gas Analyzer (AG200)

K250148 · Prior Care Science Technology, Ltd. · Anesthesiology

Aug 2025

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K250148 is an FDA 510(k) clearance for the Medical Gas Analyzer (AG200), a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Prior Care Science Technology, Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on August 28, 2025, 219 days after receiving the submission on January 21, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number	K250148 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 21, 2025
Decision Date	August 28, 2025
Days to Decision	219 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF