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Smart Check O2 (MA0236)

by Life Spark Medical, LLC

510(k) K250002

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250002 Date24 Apr 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
CCL
Device Class
Class II
Regulation
21 CFR Part 868.1720
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Smart Check O2 (MA0236) is a gaseous-phase oxygen gas analyzer. It is designed to measure oxygen purity, flow, and pressure.

This device is authorized under FDA 510(k) clearance K250002. It is a battery-operated, maintenance-free unit.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Smart Check O2?

    The Smart Check O2 is a gaseous-phase oxygen gas analyzer designed to measure three specific parameters: oxygen purity, gas flow, and gas pressure.

  • Does the Smart Check O2 require regular maintenance?

    No, the device is designed as a maintenance-free unit, which simplifies its use in clinical environments by removing the need for routine servicing.

  • How is the Smart Check O2 powered?

    The device is battery-operated, allowing for portable use and operation without the need for a constant external power connection.

  • What is the regulatory status of this device?

    The Smart Check O2 (MA0236) is authorized under FDA 510(k) clearance K250002, which indicates it has been determined to be substantially equivalent to legally marketed predicate devices.