Oemedic International Inc. Besmed Silicone Adult, Child, Infant Manual Resuscitator with Mask and Reservoir
FDA 510(k) K021446 · Oemedic International, Inc.
510(k) numberK021446
Submission
- Device name
- Oemedic International Inc. Besmed Silicone Adult, Child, Infant Manual Resuscitator with Mask and Reservoir
- Applicant
- Oemedic International, Inc.
Littleton, CO, US - Received
- May 6, 2002
- Decision date
- October 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K021442 | Oemedic International Inc. Besmed Single Use Adult, Child, Infant Manual Resuscitator…BTM · Traditional | 07/30/2002SE |
Questions and answers
When was Oemedic International Inc. Besmed Silicone Adult, Child, Infant Manual Resuscitator with Mask and Reservoir cleared by the FDA?
Oemedic International Inc. Besmed Silicone Adult, Child, Infant Manual Resuscitator with Mask and Reservoir (K021446) received a 510(k) decision of Substantially Equivalent on October 11, 2002, 158 days after the submission was received.
What is the product code of K021446?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.