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510(k) K081516

MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT by Medsource International, LLC — Product Code CBP

K081516 is an FDA 510(k) premarket notification submitted by Medsource International, LLC for the device "MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT". The FDA issued a decision of Substantially Equivalent on August 26, 2008. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Medsource International, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2008
Date Received
May 30, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Medsource International, LLC

  • K223788 — The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource Cle (September 15, 2023)
  • K161779 — MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV Cath (November 3, 2016)
  • K150611 — MedSource ClearSafe Safety IV Catheter (July 15, 2015)
  • K150333 — MedSource Sharps Dart (May 8, 2015)
  • K140442 — MEDSOURCE SELECTABLE IV SET (April 22, 2014)
  • K140402 — MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS M (April 3, 2014)
  • K131555 — MEDSOURCE IV SAFETY CATHETER (January 31, 2014)
  • K120424 — MEDSOURCE IV ADMINSTRATION SET (July 11, 2012)
  • K080339 — MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) (October 27, 2008)

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