Valve, Non-Rebreathing
FDA product code CBP · Class II (moderate risk) · 21 CFR 868.5870 · Anesthesiology
103510(k) clearances
0PMA approvals
3recalls
Manufacturers
- Instrumentation Industries, Inc. 7
- Rondex Products, Inc. 6
- Plasco, Inc. 5
- Mem Medical, Inc. 4
- Protectaide, Inc. 4
- Fisher & Paykel Healthcare, Ltd. 3
- O-Two Systems Intl., Inc. 3
- Hudson Oxygen Therapy Sales Co. 2
- Cal West Trading Co. 2
- Certified Safety Mfg., Inc. 2
- Spiracle Technology 2
- Mtm Health Products , Ltd. 2
- Intersurgical, Inc. 2
- Wet Nose Technologies, LLC 2
- Tagg Industries 2
- Laerdal Medical Corp. 2
- Sensor Medics Corp. 2
- Dhd Medical Products Div. Diemolding Corp. 2
- Airlife, Inc. 2
- Genuine First Aid, LLC 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241366 | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)CBP · Traditional | Dehas Medical Systems GmbH | 10/29/2024SE |
| K234053 | F&P Optiflow Flow DiverterCBP · Traditional | Fisher & Paykel Healthcare, Ltd. | 08/09/2024SE |
| K210992 | Altech® Exhalation Valve (Single Limb and Dual Limb)CBP · Traditional | Meditera Tibbi Malzeme San VE Tic AS | 12/23/2021SE |
| K192285 | CPR Face ShieldCBP · Traditional | Firstar Healthcare Company Limited (Guangzhou) | 11/25/2020SE |
| K173770 | OJR215 Pressure Relief ManifoldCBP · Traditional | Fisher & Paykel Healthcare Limited | 04/05/2019SE |
| K171961 | Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower…CBP · Traditional | Xiamen Compower Medical Tech. Co., Ltd. | 11/17/2017SE |
| K152521 | Seal Rite Non-Rebreathing ValveCBP · Traditional | The Lifeguard Store, Inc. | 06/03/2016SE |
| K142764 | KYOLING CPR Mask with Oxygen Port and Without Oxygen PortCBP · Traditional | Hangzhou Jinlin Medical Appliances Co., Ltd. | 07/09/2015SE |
| K142402 | BigEasy Non-Rebreathing ValveCBP · Traditional | 12th Man Technologies, Inc. | 03/23/2015SE |
| K132143 | Exhalation ValveCBP · Traditional | Intersurgical Incorporated | 06/04/2014SE |
| K112126 | Genuine First Aid CPR MaskCBP · Traditional | Genuine First Aid, LLC | 12/01/2011SE |
| K111191 | Audible Pressure Release Valve with Humidifier Adapter / and Oxygen NippleCBP · Special | Wet Nose Technologies, LLC | 07/28/2011SE |
| K102299 | CPR Face MaskCBP · Traditional | Genuine First Aid, LLC | 03/18/2011SE |
| K083418 | CPR MaskCBP · Traditional | Firstar Healthcare Co., Ltd. | 07/22/2010SE |
| K091538 | Pressure Release Valve W/Audible, Model PRV 20/40/60; with T6 Adapter, Model PRV…CBP · Traditional | Wet Nose Technologies, LLC | 03/25/2010SE |
| K082345 | Oxygen Demand ValveCBP · Traditional | Bpr Medical, Ltd. | 03/13/2009SE |
| K081516 | Medsource CPR Mask with & Without Oxygen PortCBP · Traditional | Medsource International, LLC | 08/26/2008SE |
| K052458 | Liv Medica CPR Face MaskCBP · Traditional | Liv Medica Products Pvt. , Ltd. | 07/07/2006SE |
| K052743 | Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921CBP · Traditional | Dynarex Corp. | 12/22/2005SE |
| K042727 | Pocket Size Resuscitator/Model: M16201R and M16201ACBP · Traditional | Foremount Ent. Co., Ltd. | 03/18/2005SE |
| K031397 | Merlin E-MaskCBP · Traditional | Merlin Medical Limited | 07/29/2004SE |
| K031431 | Bawmed Rescue MaskCBP · Traditional | Bawmed UK | 07/13/2004SE |
| K040366 | Pressure Manifold, Model BC 110CBP · Traditional | Fisher & Paykel Healthcare, Ltd. | 03/04/2004SE |
| K030943 | Modification to HioxCBP · Traditional | Sensor Medics Corp. | 04/22/2003SE |
| K023805 | Laerdal Paediatric Pocket Mask, Model 820050CBP · Special | Laerdal Medical A/S | 02/11/2003SE |
| K020665 | Hi-OxCBP · Traditional | Sensor Medics Corp. | 07/30/2002SE |
| K010191 | Y2000 Pocket RescueCBP · Traditional | Cheen Houng Ent. Co. , Ltd. | 03/14/2001SE |
| K001742 | Resusci Inflate-A-Shield CPR BarrierCBP · Traditional | Laerdal Medical Corp. | 10/06/2000SE |
| K993528 | Rusch Emergency MaskCBP · Traditional | Rusch, Inc. | 05/31/2000SE |
| K991617 | FACE-2-FACE CPR Protection ShieldCBP · Traditional | Whiteline Plastics, Inc. | 11/03/1999SE |
| K983631 | Auto-Peep Measurement Device, Model # KC 9-PCBP · Traditional | Instrumentation Industries, Inc. | 07/01/1999SE |
| K983919 | EMS Mouth to Mask ResuscitatorsCBP · Traditional | Engineered Medical Systems | 04/07/1999SE |
| K984481 | Exhalation ValveCBP · Traditional | Intersurgical, Inc. | 01/29/1999SE |
| K980725 | Exhalation Valve (Be 30-115-B, NS 30-115-U, NS 30-115-5, PS 54-A)CBP · Traditional | Instrumentation Industries, Inc. | 08/24/1998SE |
| K980052 | RespaideCBP · Traditional | Emergency Filtration Products, Inc. | 08/05/1998SE |
| K981169 | Rondex CPR Iso-ShieldCBP · Traditional | Rondex Products, Inc. | 05/19/1998SE |
| K973066 | Non-Rebreathing 'T' (Be 117)CBP · Traditional | Instrumentation Industries, Inc. | 02/03/1998SE |
| K970780 | One-Way Valve (with Connector)CBP · Traditional | Instrumentation Industries, Inc. | 09/18/1997SE |
| K960587 | Cprotector 2000CBP · Traditional | Certified Safety Mfg., Inc. | 07/21/1997SE |
| K963755 | Spiracle Technology - Model 302 Ox InhalatorCBP · Traditional | Spiracle Technology | 04/08/1997SE |
| K960995 | CPR Bio-Barrier FacesheildCBP · Traditional | O-Two Systems Intl., Inc. | 01/07/1997SE |
| K955520 | Rescue BreatherCBP · Traditional | International Safety, Inc. | 10/08/1996SE |
| K954426 | CPR Life Mask Compact BarrierCBP · Traditional | Carefree Trading, Inc. | 09/16/1996SESK |
| K955634 | Montgomery Tracheostomy Speaking ValveCBP · Traditional | Boston Medical Products, Inc. | 06/10/1996SE |
| K953414 | CPR Micromask with Oxygen InletCBP · Traditional | Plasco, Inc. | 03/20/1996SE |
| K953349 | Spiracle Technoloty Gaseous Oxygen Supply ValveCBP · Traditional | Spiracle Technology | 02/29/1996SE |
| K953230 | CPR Super Pocket PackCBP · Traditional | Formosa-Cj Health Business Corp. | 02/14/1996SE |
| K953461 | CPR Mask & Related Family KitsCBP · Traditional | Safetec of America, Inc. | 01/04/1996SE |
| K951483 | CPR MicromaskCBP · Traditional | Plasco, Inc. | 10/19/1995SE |
| K940820 | Pershield CPR DeviceCBP · Traditional | Rabintex Industries, Ltd. | 09/25/1995SE |
| K946225 | 3M Filtrete(Tm) Air Filter MediaCBP · Traditional | Tagg Industries | 05/25/1995SE |
| K940503 | Mouth-To-Mask ResuscitatorCBP · Traditional | Mtm Health Products , Ltd. | 03/23/1995SE |
| K950770 | CPR Microshield IICBP · Traditional | Plasco, Inc. | 03/10/1995SE |
| K950769 | CPR Micromask Plus Catalog No 73-402CBP · Traditional | Plasco, Inc. | 03/10/1995SE |
| K945822 | Capno-Flo(Tm) RegulatorCBP · Traditional | Kirk Specialty Systems | 02/24/1995SE |
| K950392 | 4-O2 Plus (CPR) Mouth Barrier, Catalog No. 08050CBP · Traditional | Cal West Trading Co. | 02/21/1995SE |
| K943386 | CPR MicromaskCBP · Traditional | Plasco, Inc. | 02/21/1995SE |
| K942671 | CPR ShieldCBP · Traditional | Rondex Products, Inc. | 02/07/1995SE |
| K940712 | PPM IIICBP · Traditional | O-Two Systems Intl., Inc. | 11/14/1994SE |
| K943761 | Non-Breathing ValveCBP · Traditional | Rondex Products, Inc. | 11/10/1994SESK |
| K941008 | Complete CPR KitCBP · Traditional | Mtm Health Products , Ltd. | 11/10/1994SESK |
| K945177 | 4-O2 Jr. (CPR Mouth Barrier)CBP · Traditional | Eagle Health Supplies | 11/01/1994SE |
| K942469 | Protectaide CPR Protection PackCBP · Traditional | Protectaide, Inc. | 10/31/1994SE |
| K942468 | Protectaide CPR Protection Pack No. 22100CBP · Traditional | Protectaide, Inc. | 10/31/1994SE |
| K940927 | Rescue BreatherCBP · Traditional | O-Two Systems Intl., Inc. | 10/14/1994SE |
| K942467 | Protectaide Aviator CPR Protection Pack No. 31000CBP · Traditional | Protectaide, Inc. | 10/06/1994SE |
| K942466 | Protectaide CPR Protection Pack No. 17701CBP · Traditional | Protectaide, Inc. | 10/06/1994SE |
| K943402 | K.P.R. (King Personal Resuscitator)CBP · Traditional | King Systems Corp. | 08/19/1994SE |
| K942021 | Mouth to Mouth BreatherCBP · Traditional | Gam Industries, Inc. | 06/22/1994SE |
| K934821 | CprotectorCBP · Traditional | Certified Safety Mfg., Inc. | 01/06/1994SE |
| K933756 | Magnashield CPR Mouth BarrierCBP · Traditional | Cal West Trading Co. | 01/05/1994SE |
| K913163 | Non Rebreathing ValveCBP · Traditional | Specialty Packaging Producs, Inc. | 02/03/1992SE |
| K914195 | Rondex CPR Non Rebreathing Valve #9030, ModifiedCBP · Traditional | Rondex Products, Inc. | 11/08/1991SE |
| K902299 | CPR Valve (Non-Rebreathing) Model #9030CBP · Traditional | Rondex Products, Inc. | 10/26/1990SE |
| K891124 | Non-Rebreathing Airway and Mask(S) KitsCBP · Traditional | Airway Products, Inc. | 10/13/1989SE |
| K884543 | LSP Demand Inhalator Valve Model SPOO68 W/MaskCBP · Traditional | Sechrist Industries, Inc. | 12/13/1988SE |
| K883383 | Lifeguard Vent MaskCBP · Traditional | Breath of Life, Inc. | 11/21/1988SE |
| K883988 | Non-Rebreathing Tee Piece (NRTP)CBP · Traditional | Dhd Medical Products Div. Diemolding Corp. | 10/07/1988SE |
| K881931 | Rescue Mask & CPR Valve for Mouth-To-Mask Type CPRCBP · Traditional | Rondex Products, Inc. | 07/21/1988SE |
| K882204 | Resuscitator Valve Assembly W/FilterCBP · Traditional | Intertech/Ohio | 07/08/1988SE |
| K873570 | Lifecare Exhalation Valve #06-699CBP · Traditional | Lifecare Services, Inc. | 11/30/1987SE |
| K871367 | Hy-Flow Non-Rebreathing Valve AssemblyCBP · Traditional | Med Air Technology, Inc. | 06/19/1987SE |
| K864681 | Carhill One-Way Resuscitation ValveCBP · Traditional | Life Design Systems, Inc. | 05/21/1987SE |
| K870895 | No. 1552, Valved Venti-CompCBP · Traditional | Hudson Oxygen Therapy Sales Co. | 05/04/1987SE |
| K870382 | DRV Disp Resuscit 3000/BAG Adapt 3010 & 3011CBP · Traditional | Nova-Ventrx | 03/06/1987SE |
| K870253 | Inspiron(R) Breath for Life Emerg. ResuscitatorCBP · Traditional | Intertech Resources, Inc. | 03/06/1987SE |
| K870138 | 1160 Simple Isolation Valve & 1161 Filtered ValveCBP · Traditional | Hudson Oxygen Therapy Sales Co. | 03/06/1987SE |
| K864472 | Person to Person Valve-Mask & Tri-Seal Face MaskCBP · Traditional | Tagg Industries | 01/12/1987SE |
| K861401 | Laerdal Pocket MaskCBP · Traditional | Laerdal Medical Corp. | 05/21/1986SE |
| K855218 | Rondex CPR ValveCBP · Traditional | Kondex Products, Inc. | 02/12/1986SE |
| K833748 | Rescue ValveCBP · Traditional | Respironics, Inc. | 12/08/1983SE |
| K832868 | Resuscitation ValveCBP · Traditional | Boehringer Laboratories | 09/26/1983SE |
| K831246 | Whistler In-Line Pressure Release ValveCBP · Traditional | Airlife, Inc. | 07/26/1983SE |
| K810348 | CM 3CBP · Traditional | Instrumentation Industries, Inc. | 02/23/1981SE |
| K791908 | Retard Valve 3-STACK #M-514CBP · Traditional | Mem Medical, Inc. | 10/09/1979SE |
| K791907 | Retard Valve 3-STACK #M-515CBP · Traditional | Mem Medical, Inc. | 10/09/1979SE |
| K791850 | One-Way Valve-Female, M-503CBP · Traditional | Mem Medical, Inc. | 10/01/1979SE |
| K791849 | One-Way Valve-Male, M-504CBP · Traditional | Mem Medical, Inc. | 10/01/1979SE |
| K790820 | Non-Rebreathing T PieceCBP · Traditional | Dhd Medical Products Div. Diemolding Corp. | 05/04/1979SE |
| K790151 | One-Way ValveCBP · Traditional | Airlife, Inc. | 03/12/1979SE |
| K781920 | Valve, Vent-Away Two-WayCBP · Traditional | Chesebrough-Pond'S U.S.A. Co. | 12/04/1978SE |
| K770629 | Valve, Exhalation Be 115-4, 115-5CBP · Traditional | Instrumentation Industries, Inc. | 05/23/1977SE |
| K770627 | Adapter, Valve, One Way BE-130-22CBP · Traditional | Instrumentation Industries, Inc. | 05/23/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2133-2016 Class II | 5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter… | Lifeline First Aid LLC | 05/16/2016Terminated |
| Z-2132-2016 Class II | Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter.…First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and… | Lifeline First Aid LLC | 05/16/2016Terminated |
| Z-2117-2014 Class II | CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label…"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong… | Dynarex Corporation | 07/02/2014Terminated |