Resuscitation Bag Controller (RBC)
FDA 510(k) K882278 · Physician Engineered Products, Inc.
510(k) numberK882278
Submission
- Device name
- Resuscitation Bag Controller (RBC)
- Applicant
- Physician Engineered Products, Inc.
Park Rapids, MN, US - Received
- June 1, 1988
- Decision date
- June 16, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5915
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BTM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251631 | The BAG manual resuscitator and accessoriesBTM · Traditional | Laerdal Medical AS | 11/24/2025SE |
| K243861 | butterflyBVMBTM · Traditional | Compact Medical, Inc. | 04/25/2025SE |
| K221841 | EOlife®BTM · Traditional | Archeon | 03/18/2023SE |
| K212905 | Sotair DeviceBTM · Traditional | Safe Bvm Corporation | 08/18/2022SE |
| K210288 | Disposable Manual ResuscitatorBTM · Traditional | Xiamen Compower Medical Tech. Co., Ltd. | 08/26/2021SE |
| K181583 | Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator…BTM · Traditional | Flexicare Medical Limited. | 12/07/2018SE |
| K170663 | Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount…BTM · Traditional | Foremount Enterprise Co., Ltd. | 05/11/2018SE |
| K152931 | Ambu SPUR II Adult Resuscitator, Ambu SPUR II Pediatric Resuscitator, Ambu SPUR II…BTM · Abbreviated | Ambu A/S | 08/29/2016SE |
| K132172 | Neonatalie ResuscitatorBTM · Abbreviated | Laerdal Medical A/S | 01/15/2015SE |
| K112852 | Babi Plus Neonatal Resuscitation BagBTM · Traditional | A Plus Medical | 01/13/2012SE |
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| K110550 | Bright Embrace Model SBL60LBI · Traditional | 02/03/2012SE |
| K093618 | Bili-Mirror Model BLM-1LBI · Traditional | 04/23/2010SE |
| K974830 | Ultra Bili LightLBI · Traditional | 05/20/1998SE |
| K883818 | Modified Reflux ReducerFMS · Traditional | 11/21/1988SE |
| K882291 | Retrofit Baby Face Shield (RFS)LBI · Traditional | 06/20/1988SE |
| K873700 | Institutional Bili Light (Ibl)LBI · Traditional | 12/11/1987SE |
| K850599 | Home Bili Lights-Model 100LBI · Traditional | 06/17/1985SE |
Questions and answers
When was Resuscitation Bag Controller (RBC) cleared by the FDA?
Resuscitation Bag Controller (RBC) (K882278) received a 510(k) decision of Substantially Equivalent on June 16, 1988, 15 days after the submission was received.
What is the product code of K882278?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.