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510(k) K902299

CPR VALVE (NON-REBREATHING) MODEL #9030 by Rondex Products, Inc. — Product Code CBP

K902299 is an FDA 510(k) premarket notification submitted by Rondex Products, Inc. for the device "CPR VALVE (NON-REBREATHING) MODEL #9030". The FDA issued a decision of Substantially Equivalent on October 26, 1990. The device falls under product code CBP (Valve, Non-Rebreathing), a Class II device regulated under 21 CFR 868.5870. Rondex Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1990
Date Received
May 22, 1990
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 Rondex Products, Inc.

  • K981169 — RONDEX CPR ISO-SHIELD (May 19, 1998)
  • K942671 — CPR SHIELD (February 7, 1995)
  • K943761 — NON-BREATHING VALVE (November 10, 1994)
  • K921002 — RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIED (October 6, 1992)
  • K914195 — RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED (November 8, 1991)
  • K914196 — RONDEX MASKS MODELS 9015/9011/901102 MODIFIED (November 8, 1991)
  • K902298 — ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GAS (August 22, 1990)
  • K881931 — RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPR (July 21, 1988)
  • K881393 — RONDEX RESCUE MASK (April 25, 1988)
  • K834250 — RESCUE MASK (January 18, 1984)

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