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510(k) K221734

Maxtec MaxO2 ME+p by Maxtec, LLC — Product Code CCL

K221734 is an FDA 510(k) premarket notification submitted by Maxtec, LLC for the device "Maxtec MaxO2 ME+p". The FDA issued a decision of Substantially Equivalent on April 1, 2023. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Maxtec, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2023
Date Received
June 15, 2022
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 by Maxtec, LLC

  • K231895 — Maxtec MaxBlend2+p (December 4, 2023)
  • K182362 — MaxCap Ped and MaxCap Neo (May 23, 2019)
  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K153659 — MaxO2ME (June 10, 2016)
  • K133540 — FLOCAP (March 28, 2014)
  • K113232 — MAXMIXING BLOCK (March 1, 2012)
  • K112402 — ULTRAMAXO2 OXYGEN ANALYER (December 14, 2011)
  • K063488 — MAXO2 CU (February 22, 2007)
  • K040484 — MAXO2+, MODEL A AND AE (June 9, 2004)

Other clearances for product code CCL

  • K251245 — OxyMinder Pro (10310) (August 11, 2025)
  • K250002 — Smart Check O2 (MA0236) (April 24, 2025)
  • 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