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510(k) K112126

GENUINE FIRST AID CPR MASK by Genuine First Aid, LLC — Product Code CBP

K112126 is an FDA 510(k) premarket notification submitted by Genuine First Aid, LLC for the device "GENUINE FIRST AID CPR MASK". The FDA issued a decision of Substantially Equivalent on December 1, 2011. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Genuine First Aid, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2011
Date Received
July 25, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

Other clearances by Genuine First Aid, LLC

  • K102299 — CPR FACE MASK (March 18, 2011)

Other clearances for product code CBP

  • K241366 — QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MT (October 29, 2024)
  • K234053 — F&P Optiflow Flow Diverter (August 9, 2024)
  • K210992 — Altech® Exhalation Valve (Single Limb and Dual Limb) (December 23, 2021)
  • K192285 — CPR Face Shield (November 25, 2020)
  • K173770 — OJR215 Pressure Relief Manifold (April 5, 2019)
  • K171961 — Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compo (November 17, 2017)
  • K152521 — Seal Rite Non-Rebreathing Valve (June 3, 2016)
  • K142764 — KYOLING CPR Mask with Oxygen Port and Without Oxygen Port (July 9, 2015)
  • K142402 — BigEasy Non-Rebreathing Valve (March 23, 2015)
  • K132143 — EXHALATION VALVE (June 4, 2014)

FDA data resources