Lspi Disposable Bag Mask Resuscitator/Modified
FDA 510(k) K924217 · Life Support Products, Inc.
510(k) numberK924217
Submission
- Device name
- Lspi Disposable Bag Mask Resuscitator/Modified
- Applicant
- Life Support Products, Inc.
Irvine, CA, US - Received
- August 19, 1992
- Decision date
- September 17, 1992
- 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 |
|---|---|---|
| K941871 | Lspi Automatic Ventilator, Model AV3000-100BTL · Traditional | 01/09/1995SE |
| K941870 | Lspi Automatic Ventilator, Model AV2000-100BTL · Traditional | 01/09/1995SE |
| K940934 | Life VacBTA · Traditional | 05/03/1994SE |
| K936187 | Lspi Pressure RegulatorCAN · Traditional | 01/27/1994SE |
| K932200 | Lspi Automatic VentilatorBTL · Traditional | 11/24/1993SE |
| K932199 | Lspi Automatic Ventilator, Model AV3000BTL · Traditional | 11/24/1993SE |
| K922819 | Infant Disposable Bag Mask ResuscitatorBTM · Traditional | 11/24/1993SE |
| K922691 | LSP (Model 554) Bag Mask ResuscitatorBTM · Traditional | 11/24/1993SE |
| K921553 | Lspi Infant Bag MaskBTM · Traditional | 10/19/1992SE |
| K921107 | AutovacBTA · Traditional | 09/17/1992SE |
Questions and answers
When was Lspi Disposable Bag Mask Resuscitator/Modified cleared by the FDA?
Lspi Disposable Bag Mask Resuscitator/Modified (K924217) received a 510(k) decision of Substantially Equivalent on September 17, 1992, 29 days after the submission was received.
What is the product code of K924217?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.