Pulmanex TM (Modification)
FDA 510(k) K863026 · Life Design Systems, Inc.
510(k) numberK863026
Submission
- Device name
- Pulmanex TM (Modification)
- Applicant
- Life Design Systems, Inc.
Milwaukee, WI, US - Received
- August 11, 1986
- Decision date
- August 26, 1986
- 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 |
More from A Plus Medical
| 510(k) | Device | Decision |
|---|---|---|
| K913714 | Modification Manual Pulmon Resuscitor/Pulmanex(Tm)BTM · Traditional | 12/01/1992SE |
| K885313 | Humidi-Flex TMBYD · Traditional | 10/11/1989SE |
| K893030 | Child Size - Filter Flex (TM)CAH · Traditional | 09/18/1989SE |
| K892862 | Flex-Cup PercussorBYI · Traditional | 05/25/1989SE |
| K892221 | Pulmonary Resuscitator, ModificationBTM · Traditional | 05/18/1989SE |
| K890011 | Oxygen Connector and Oxygen Delivery TubingBZO · Traditional | 03/20/1989SE |
| K890108 | Modified Cushion-Flex(Tm)BSJ · Traditional | 01/24/1989SE |
| K884387 | Cushion Flex(Tm)BSJ · Traditional | 11/17/1988SE |
| K884068 | Pulmanex TM (Neo-Natal Size)BTM · Traditional | 11/16/1988SE |
| K873179 | Heater Wire Breathing CircuitBZE · Traditional | 03/31/1988SE |
Questions and answers
When was Pulmanex TM (Modification) cleared by the FDA?
Pulmanex TM (Modification) (K863026) received a 510(k) decision of Substantially Equivalent on August 26, 1986, 15 days after the submission was received.
What is the product code of K863026?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.