Reusable Full Silicone Cover
FDA 510(k) K151702 · Laerdal Medical AS
510(k) numberK151702
Submission
- Device name
- Reusable Full Silicone Cover
- Applicant
- Laerdal Medical AS
Stavanger, NO - Received
- June 24, 2015
- Decision date
- August 13, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIX – Aid, Cardiopulmonary Resuscitation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5210
- Specialty
- Cardiovascular
CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both. Device contains software
Other 510(k)s with product code LIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201581 | CPR BandLIX · Traditional | Credo | 03/06/2021SE |
| K183348 | Reusable Silicone Cover CPRmeter 2LIX · Special | Laerdal Medical AS | 12/17/2018SE |
| K173886 | CPRmeter 2 CPR Feedback DeviceLIX · Traditional | Laerdal Medical AS | 03/23/2018SE |
| K123248 | CPR RSQ AssistLIX · Traditional | Avantech, Inc. | 12/10/2013SE |
| K123597 | Truecpr Coaching DeviceLIX · Traditional | Physio-Control, Inc. | 04/17/2013SE |
| K122050 | Cprmeter CPR Feedback DeviceLIX · Traditional | Laerdal Medical A/S | 10/22/2012SE |
| K112660 | PocketcprLIX · Abbreviated | Zoll Medical Corp | 05/10/2012SE |
| K092408 | Rhythm of Life, Model R0901-05LIX · Traditional | Rapid Response Solutions, LLC | 10/14/2009SE |
| K071321 | PocketcprLIX · Traditional | Bio-Detek, Inc. | 09/12/2007SE |
| K010526 | Modification to the GripLIX · Traditional | Elcare Innovations, Inc. | 12/13/2001SE |
More from Elcare Innovations, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251631 | The BAG manual resuscitator and accessoriesBTM · Traditional | 11/24/2025SE |
| 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 |
| 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 Reusable Full Silicone Cover cleared by the FDA?
Reusable Full Silicone Cover (K151702) received a 510(k) decision of Substantially Equivalent on August 13, 2015, 50 days after the submission was received.
What is the product code of K151702?
The FDA product code is LIX – Aid, Cardiopulmonary Resuscitation, a Class II (moderate risk) device regulated under 21 CFR 870.5210.