Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
FDA 510(k) K170663 · Foremount Enterprise Co., Ltd.
510(k) numberK170663
Submission
- Device name
- Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
- Applicant
- Foremount Enterprise Co., Ltd.
Taichung City, TW - Received
- March 6, 2017
- Decision date
- May 11, 2018
- 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 |
| 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 |
| K102824 | Ambu Oval Silicone Resuscitator, Adult and PediatricBTM · Abbreviated | Ambu A/S | 01/28/2011SE |
Questions and answers
When was Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer cleared by the FDA?
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer (K170663) received a 510(k) decision of Substantially Equivalent on May 11, 2018, 431 days after the submission was received.
What is the product code of K170663?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.