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510(k) K142402

BigEasy Non-Rebreathing Valve by 12th Man Technologies, Inc. — Product Code CBP

K142402 is an FDA 510(k) premarket notification submitted by 12th Man Technologies, Inc. for the device "BigEasy Non-Rebreathing Valve". The FDA issued a decision of Substantially Equivalent on March 23, 2015. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. 12th Man Technologies, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2015
Date Received
August 27, 2014
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 12th Man Technologies, Inc.

  • K151933 — BRX PRO Bruxism Guard (December 10, 2015)

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)
  • K132143 — EXHALATION VALVE (June 4, 2014)
  • K112126 — GENUINE FIRST AID CPR MASK (December 1, 2011)

FDA data resources