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510(k) K231895

Maxtec MaxBlend2+p by Maxtec, LLC — Product Code BZR

K231895 is an FDA 510(k) premarket notification submitted by Maxtec, LLC for the device "Maxtec MaxBlend2+p". The FDA issued a decision of Substantially Equivalent on December 4, 2023. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Maxtec, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 2023
Date Received
June 28, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mixer, Breathing Gases, Anesthesia Inhalation
Device Class
Class II
Regulation Number
868.5330
Review Panel
AN
Submission Type

Other clearances by Maxtec, LLC

  • K221734 — Maxtec MaxO2 ME+p (April 1, 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 BZR

  • K243917 — F&P Optiflow Air/Oxygen Flow Source (July 14, 2025)
  • K241465 — Midas Flowmeter; eAVS (September 19, 2024)
  • K230987 — FlowStar Analog Mixer Flowmeter (September 14, 2023)
  • K222794 — FlowStar Touch Digital Mixer Flowmeter (July 28, 2023)
  • K221494 — Quality Mix Blender, Oxymixer (January 23, 2023)
  • K202480 — Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 (April 22, 2021)
  • K173205 — Equinox Advantage (August 29, 2018)
  • K161718 — MaxBlend 2, MaxBlend Lite (October 27, 2016)
  • K142291 — GMX Series Medical Air/Oxygen Blender (May 19, 2015)
  • K113687 — EQUINOX RELIEVE (April 30, 2012)

FDA data resources