OJR215 Pressure Relief Manifold
FDA 510(k) K173770 · Fisher & Paykel Healthcare Limited
510(k) numberK173770
Submission
- Device name
- OJR215 Pressure Relief Manifold
- Applicant
- Fisher & Paykel Healthcare Limited
Auckland, NZ - Received
- December 11, 2017
- Decision date
- April 5, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CBP – Valve, Non-Rebreathing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5870
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBP
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|---|---|---|---|
| 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 |
| 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 |
More from Genuine First Aid, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special | 12/19/2025SE |
| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS…SGR · Traditional | 11/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | 09/10/2025SE |
| K243917 | F&P Optiflow Air/Oxygen Flow SourceBZR · Traditional | 07/14/2025SE |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special | 06/25/2025SE |
| K243583 | F&P Nova Nasal MaskBZD · Traditional | 06/18/2025SE |
| K234053 | F&P Optiflow Flow DiverterCBP · Traditional | 08/09/2024SE |
| K233643 | F&P Airvo 3 NIV (PT311US)MNT · Traditional | 08/09/2024SE |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)BTT · Traditional | 08/08/2024SE |
| K233821 | F&P Optiflow Oxygen Kit (AA451J)BTT · Traditional | 06/13/2024SE |
Questions and answers
When was OJR215 Pressure Relief Manifold cleared by the FDA?
OJR215 Pressure Relief Manifold (K173770) received a 510(k) decision of Substantially Equivalent on April 5, 2019, 480 days after the submission was received.
What is the product code of K173770?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.