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510(k) K251245

OxyMinder Pro (10310) by Bio-Med Device, Inc. — Product Code CCL

K251245 is an FDA 510(k) premarket notification submitted by Bio-Med Device, Inc. for the device "OxyMinder Pro (10310)". The FDA issued a decision of Substantially Equivalent on August 11, 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
August 11, 2025
Date Received
April 22, 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

  • K250002 — Smart Check O2 (MA0236) (April 24, 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