Cleared Traditional

OxyMinder Pro (10310)

K251245 · Bio-Med Device, Inc. · Anesthesiology
Aug 2025
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K251245 is an FDA 510(k) clearance for the OxyMinder Pro (10310), a Analyzer, Gas, Oxygen, Gaseous-phase (Class II — Special Controls, product code CCL), submitted by Bio-Med Device, Inc. (Guilford, US). The FDA issued a Cleared decision on August 11, 2025, 111 days after receiving the submission on April 22, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1720.

Submission Details

510(k) Number K251245 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 2025
Decision Date August 11, 2025
Days to Decision 111 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