BigEasy Non-Rebreathing Valve
FDA 510(k) K142402 · 12th Man Technologies, Inc.
510(k) numberK142402
Submission
- Device name
- BigEasy Non-Rebreathing Valve
- Applicant
- 12th Man Technologies, Inc.
Garden Grove, CA, US - Received
- August 27, 2014
- Decision date
- March 23, 2015
- 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
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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 |
| 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 |
|---|---|---|
| K151933 | BRX PRO Bruxism GuardMQC · Traditional | 12/10/2015SE |
Questions and answers
When was BigEasy Non-Rebreathing Valve cleared by the FDA?
BigEasy Non-Rebreathing Valve (K142402) received a 510(k) decision of Substantially Equivalent on March 23, 2015, 208 days after the submission was received.
What is the product code of K142402?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.