Cleared Traditional

Smart Check O2 (MA0236)

K250002 · Life Spark Medical, LLC · Anesthesiology
Apr 2025
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K250002 is an FDA 510(k) clearance for the Smart Check O2 (MA0236), a Analyzer, Gas, Oxygen, Gaseous-phase (Class II — Special Controls, product code CCL), submitted by Life Spark Medical, LLC (Washington, US). The FDA issued a Cleared decision on April 24, 2025, 112 days after receiving the submission on January 2, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number K250002 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2025
Decision Date April 24, 2025
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCL — Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1720