Bagright Resposable Child Resuscitator
FDA 510(k) K961331 · Medical Marketing Concepts
510(k) numberK961331
Submission
- Device name
- Bagright Resposable Child Resuscitator
- Applicant
- Medical Marketing Concepts
Roanoke, VA, US - Received
- April 8, 1996
- Decision date
- June 28, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
More from A Plus Medical
| 510(k) | Device | Decision |
|---|---|---|
| K982215 | Manual Resuscitator with AceBTM · Traditional | 09/18/1998SE |
| K961867 | Peep ValveBYE · Traditional | 08/13/1996SE |
| K961330 | Bagright Infant ResuscitatorBTM · Traditional | 07/02/1996SE |
| K961329 | Bagright Child ResuscitatorBTM · Traditional | 07/02/1996SE |
| K961882 | Resposable Infant ResuscitatorBTM · Traditional | 06/28/1996SE |
| K961868 | Resposable Child ResuscitatorBTM · Traditional | 06/28/1996SE |
| K961369 | Bagright Resposable ResuscitatorBTM · Traditional | 06/28/1996SE |
| K961332 | Bagright Resposable Infant ResuscitatorBTM · Traditional | 06/28/1996SE |
| K953546 | Manual Pulmonary ResusicitatorBTM · Traditional | 02/29/1996SE |
| K954296 | Bagright ResuscitatorBTM · Traditional | 12/20/1995SE |
Questions and answers
When was Bagright Resposable Child Resuscitator cleared by the FDA?
Bagright Resposable Child Resuscitator (K961331) received a 510(k) decision of Substantially Equivalent on June 28, 1996, 81 days after the submission was received.
What is the product code of K961331?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.