Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OxyMinder Pro (10310)

K-Number: K251245 · 2025-08-11

ApplicantBio-Med Device, Inc.
Decision Date2025-08-11
Product CodeCCL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OxyMinder Pro (10310) is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Med Device, Inc.. It received FDA 510(k) clearance on 2025-08-11 under 510(k) number K251245. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OxyMinder Pro (10310)?

OxyMinder Pro (10310) is a medical device that received FDA 510(k) clearance on 2025-08-11. The listed applicant is Bio-Med Device, Inc.. The 510(k) number is K251245.

When did OxyMinder Pro (10310) receive FDA 510(k) clearance?

OxyMinder Pro (10310) received FDA 510(k) clearance on 2025-08-11, under 510(k) number K251245.

Who is the listed applicant for OxyMinder Pro (10310)?

The FDA 510(k) record lists Bio-Med Device, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OxyMinder Pro (10310)?

The FDA product code for OxyMinder Pro (10310) is CCL.

Related Devices (Code: CCL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261389PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)Salter LabsK250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213933Percent Oxygen SensorsCareox, LLCK213948OxyMinderBio-Med Devices, Inc.K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑