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510(k) K250002

Smart Check O2 (MA0236) by Life Spark Medical, LLC — Product Code CCL

K250002 is an FDA 510(k) premarket notification submitted by Life Spark Medical, LLC for the device "Smart Check O2 (MA0236)". The FDA issued a decision of Substantially Equivalent on April 24, 2025. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2025
Date Received
January 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type

Other clearances for product code CCL

  • K251245 — OxyMinder Pro (10310) (August 11, 2025)
  • K221734 — Maxtec MaxO2 ME+p (April 1, 2023)
  • K213933 — Percent Oxygen Sensors (August 19, 2022)
  • K213948 — OxyMinder (March 17, 2022)
  • K173807 — Accu O2 Oxygen Analyzer (May 2, 2018)
  • K153659 — MaxO2ME (June 10, 2016)
  • K123195 — CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES (February 28, 2013)
  • K122290 — ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (January 23, 2013)
  • K112402 — ULTRAMAXO2 OXYGEN ANALYER (December 14, 2011)
  • K082655 — ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM (November 25, 2008)

FDA data resources