Rescue Breather
FDA 510(k) K940927 · O-Two Systems Intl., Inc.
510(k) numberK940927
Submission
- Device name
- Rescue Breather
- Applicant
- O-Two Systems Intl., Inc.
Mississauga, CA - Received
- February 28, 1994
- Decision date
- October 14, 1994
- 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 |
|---|---|---|
| K991195 | Carevent BLS, Carevent Bls+, Carevent Als, Carevent Als+, and Carevent AtvBTL · Special | 04/22/1999SE |
| K983857 | Autovent 1500BTL · Special | 11/04/1998SE |
| K983785 | Autovent 1000BTL · Special | 10/29/1998SE |
| K983705 | Emt ResuscitatorBTL · Special | 10/29/1998SE |
| K983643 | Genesis BLSBTL · Special | 10/29/1998SE |
| K960995 | CPR Bio-Barrier FacesheildCBP · Traditional | 01/07/1997SE |
| K940712 | PPM IIICBP · Traditional | 11/14/1994SE |
| K932170 | Flynnr Genesis II A/C, A/O and IdlhBTL · Traditional | 10/25/1993SE |
| K922810 | OdysseyBTM · Traditional | 01/22/1993SE |
| K913039 | Fllynn(R) Genesis AcBTL · Traditional | 08/25/1992SE |
Questions and answers
When was Rescue Breather cleared by the FDA?
Rescue Breather (K940927) received a 510(k) decision of Substantially Equivalent on October 14, 1994, 228 days after the submission was received.
What is the product code of K940927?
The FDA product code is CBP – Valve, Non-Rebreathing, a Class II (moderate risk) device regulated under 21 CFR 868.5870.