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510(k) K132143

EXHALATION VALVE by Intersurgical Incorporated — Product Code CBP

K132143 is an FDA 510(k) premarket notification submitted by Intersurgical Incorporated for the device "EXHALATION VALVE". The FDA issued a decision of Substantially Equivalent on June 4, 2014. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Intersurgical Incorporated has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2014
Date Received
July 11, 2013
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 Intersurgical Incorporated

  • K141087 — INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF (February 12, 2015)
  • K121747 — FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS (March 14, 2013)

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)
  • K112126 — GENUINE FIRST AID CPR MASK (December 1, 2011)

FDA data resources