LIX — Aid, Cardiopulmonary Resuscitation Class II
FDA product code LIX covers "Aid, Cardiopulmonary Resuscitation", a Class II medical device regulated under 21 CFR 870.5210. Submissions are reviewed by the Cardiovascular panel. At least 17 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LIX
- Device Class
- Class II
- Regulation Number
- 870.5210
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201581 | credo | CPR BAND | March 6, 2021 |
| K183348 | laerdal medical | Reusable Silicone Cover CPRmeter 2 | December 17, 2018 |
| K173886 | laerdal medical | CPRmeter 2 CPR Feedback Device | March 23, 2018 |
| K151702 | laerdal medical | Reusable Full Silicone Cover | August 13, 2015 |
| K123248 | avantech | CPR RSQ ASSIST | December 10, 2013 |
| K123597 | physio-control | TRUECPR COACHING DEVICE | April 17, 2013 |
| K122050 | laerdal medical | CPRMETER CPR FEEDBACK DEVICE | October 22, 2012 |
| K112660 | zoll medical | POCKETCPR | May 10, 2012 |
| K092408 | rapid response solutions | RHYTHM OF LIFE, MODEL R0901-05 | October 14, 2009 |
| K071321 | bio-detek | POCKETCPR | September 12, 2007 |
| K010526 | elcare innovations | MODIFICATION TO THE GRIP | December 13, 2001 |
| K003937 | medteq innovations pty | CPR EZY MASK AND PAD | June 6, 2001 |
| K954692 | county line | CPR PROMPT | March 27, 1996 |
| K926333 | kells medical | CPR PLUS | November 8, 1993 |
| K900415 | can-am medical | C.P.R. LANDMARC | June 12, 1990 |
| K843977 | james j. lally | PULSE-AID DEVICE | February 1, 1985 |
| K833737 | lifepoint | CPR LOCATOR | August 24, 1984 |