Medsource CPR Mask with & Without Oxygen Port
FDA 510(k) K081516 · Medsource International, LLC
510(k) numberK081516
Submission
- Device name
- Medsource CPR Mask with & Without Oxygen Port
- Applicant
- Medsource International, LLC
Mound, MN, US - Received
- May 30, 2008
- Decision date
- August 26, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- CBP – Valve, Non-Rebreathing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5870
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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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 |
| 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 |
More from Intersurgical Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K223788 | The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe…FOZ · Traditional | 09/15/2023SE |
| K161779 | MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterFOZ · Traditional | 11/03/2016SE |
| K150611 | MedSource ClearSafe Safety IV CatheterFOZ · Traditional | 07/15/2015SE |
| K150333 | MedSource Sharps DartMMK · Traditional | 05/08/2015SE |
| K140442 | Medsource Selectable IV SetLHI · Special | 04/22/2014SE |
| K140402 | Medsource IV Administration Set 72 Medsource IV Administration Set, Needleless Male…LHI · Special | 04/03/2014SE |
| K131555 | Medsource IV Safety CatheterFOZ · Traditional | 01/31/2014SE |
| K120424 | Medsource IV Adminstration SetLHI · Traditional | 07/11/2012SE |
| K080339 | Medsource Endotracheal Tube (with and Without Cuff)BTR · Traditional | 10/27/2008SE |
Questions and answers
When was Medsource CPR Mask with & Without Oxygen Port cleared by the FDA?
Medsource CPR Mask with & Without Oxygen Port (K081516) received a 510(k) decision of Substantially Equivalent on August 26, 2008, 88 days after the submission was received.
What is the product code of K081516?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.