The BAG manual resuscitator and accessories
FDA 510(k) K251631 · Laerdal Medical AS
510(k) numberK251631
Submission
- Device name
- The BAG manual resuscitator and accessories
- Applicant
- Laerdal Medical AS
Stavanger, NO - Received
- May 28, 2025
- Decision date
- November 24, 2025
- 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 |
|---|---|---|---|
| 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 |
| K102824 | Ambu Oval Silicone Resuscitator, Adult and PediatricBTM · Abbreviated | Ambu A/S | 01/28/2011SE |
More from Ambu A/S
| 510(k) | Device | Decision |
|---|---|---|
| K232111 | NeoBeat, NeoBeat MiniMWI · Traditional | 06/25/2024SE |
| K183348 | Reusable Silicone Cover CPRmeter 2LIX · Special | 12/17/2018SE |
| K173886 | CPRmeter 2 CPR Feedback DeviceLIX · Traditional | 03/23/2018SE |
| K151702 | Reusable Full Silicone CoverLIX · Special | 08/13/2015SE |
| K001742 | Resusci Inflate-A-Shield CPR BarrierCBP · Traditional | 10/06/2000SE |
| K962361 | Trachlight Stylet and Tracheal LightwandBSR · Traditional | 09/05/1996SE |
| K954771 | Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal…BSR · Traditional | 05/09/1996SE |
| K954609 | Heartstart 911MKJ · Traditional | 01/04/1996SE |
| K950698 | Lsu 2000 Portable Suction UnitJCX · Traditional | 05/09/1995SE |
| K933048 | Laerdal(Tm) Pocket Mask, ModificationKGB · Traditional | 12/02/1993SE |
Questions and answers
When was The BAG manual resuscitator and accessories cleared by the FDA?
The BAG manual resuscitator and accessories (K251631) received a 510(k) decision of Substantially Equivalent on November 24, 2025, 180 days after the submission was received.
What is the product code of K251631?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.