FDA 510(k)

Smart Check O2 (MA0236)

K-Number: K250002 · 2025-04-24

Decision Date2025-04-24

Product CodeCCL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Smart Check O2 (MA0236) is the device name listed in this FDA 510(k) record. The listed applicant is Life Spark Medical, LLC. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K250002. 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 Smart Check O2 (MA0236)?

Smart Check O2 (MA0236) is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Life Spark Medical, LLC. The 510(k) number is K250002.

When did Smart Check O2 (MA0236) receive FDA 510(k) clearance?

Smart Check O2 (MA0236) received FDA 510(k) clearance on 2025-04-24, under 510(k) number K250002.

Who is the listed applicant for Smart Check O2 (MA0236)?

The FDA 510(k) record lists Life Spark Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Smart Check O2 (MA0236)?

The FDA product code for Smart Check O2 (MA0236) 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 Labs K251245OxyMinder Pro (10310)Bio-Med Device, Inc.K221734Maxtec MaxO2 ME+pMaxtec, LLC K213933Percent Oxygen SensorsCareox, LLC K213948OxyMinderBio-Med Devices, Inc.K173807Accu O2 Oxygen AnalyzerPrecision Medical, Inc.

Official Source

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