Bawmed Rescue Mask
FDA 510(k) K031431 · Bawmed UK
510(k) numberK031431
Submission
- Device name
- Bawmed Rescue Mask
- Applicant
- Bawmed UK
United Kingdom, GB - Received
- May 6, 2003
- Decision date
- July 13, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
| 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 |
More from Intersurgical Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K031434 | Bawmed E-Z Bag ResuscitatorBTM · Traditional | 02/06/2004SE |
Questions and answers
When was Bawmed Rescue Mask cleared by the FDA?
Bawmed Rescue Mask (K031431) received a 510(k) decision of Substantially Equivalent on July 13, 2004, 434 days after the submission was received.
What is the product code of K031431?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.