PMX Disposable Bag Mask Resuscitator
FDA 510(k) K014071 · Allied Healthcare Products, Inc.
510(k) numberK014071
Submission
- Device name
- PMX Disposable Bag Mask Resuscitator
- Applicant
- Allied Healthcare Products, Inc.
Saint Louis, MO, US - Received
- December 10, 2001
- Decision date
- October 1, 2002
- 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 |
|---|---|---|
| K131098 | Emergency Portable VentilatorBTL · Traditional | 04/09/2014SE |
| K132021 | Ahp 300, Emergency Portable VentilatorBTL · Traditional | 04/02/2014SE |
| K090356 | Emergency Portable Ventilator, Model EPV200BTL · Traditional | 05/20/2009SE |
| K083507 | Battery Pack for MCV100 and MCV200 Emergency VentilatorsBTL · Traditional | 05/18/2009SE |
| K083385 | Mass Casualty Ventilators, Models: MCV200 and MCV200-BBTL · Traditional | 05/14/2009SE |
| K080063 | Mass Casualty Ventilator, Model MCV100BTL · Traditional | 08/15/2008SE |
| K072214 | Portable Ventilator, Model EPV-100BTL · Traditional | 03/06/2008SE |
| K073171 | Resuscitation Timer, Model L770-CPRBTM · Traditional | 01/31/2008SE |
| K070636 | Autovent 4000 with CPAPBTL · Traditional | 07/13/2007SE |
| K070120 | Autovent Model 4000BTL · Traditional | 05/03/2007SE |
Questions and answers
When was PMX Disposable Bag Mask Resuscitator cleared by the FDA?
PMX Disposable Bag Mask Resuscitator (K014071) received a 510(k) decision of Substantially Equivalent on October 1, 2002, 295 days after the submission was received.
What is the product code of K014071?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.