FDA product code LIX: Aid, Cardiopulmonary Resuscitation
LIX is the FDA product code for aid, cardiopulmonary resuscitation. It is a Class II device, regulated under 21 CFR 870.5210 and reviewed by the Cardiovascular panel. FDA has cleared 17 510(k) submissions under LIX, from 15 different applicants. The average 510(k) review took 179 days (median 147). FDA has posted 2 recalls for LIX devices.
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
Classification
| Field | Value |
|---|---|
| Device name | Aid, Cardiopulmonary Resuscitation |
| Device class | Class II |
| Regulation | 21 CFR 870.5210 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
510(k) clearances per year for LIX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 53 |
| 2021 | 1 | 268 |
Compare with all 510(k) review times · Search every LIX clearance
Top LIX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Laerdal Medical AS | 3 | 2018-12-17 |
| Credo | 1 | 2021-03-06 |
| Avantech, Inc. | 1 | 2013-12-10 |
| Physio-Control, Inc. | 1 | 2013-04-17 |
| Laerdal Medical A/S | 1 | 2012-10-22 |
10 more applicants have LIX clearances. See the full list in Caduvo.
Most recent LIX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K201581 | Credo | CPR BAND | 2021-03-06 | 268 |
| K183348 | Laerdal Medical AS | Reusable Silicone Cover CPRmeter 2 | 2018-12-17 | 14 |
| K173886 | Laerdal Medical AS | CPRmeter 2 CPR Feedback Device | 2018-03-23 | 92 |
| K151702 | Laerdal Medical AS | Reusable Full Silicone Cover | 2015-08-13 | 50 |
| K123248 | Avantech, Inc. | CPR RSQ ASSIST | 2013-12-10 | 419 |
Recalls for LIX devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-01-29.
| Year | Recalls |
|---|---|
| 2018 | 2 |
Frequently asked questions
What is FDA product code LIX?
LIX is the FDA product code for aid, cardiopulmonary resuscitation. It is a Class II device, regulated under 21 CFR 870.5210 and reviewed by the Cardiovascular panel.
What device class is LIX?
Class II, regulation 21 CFR 870.5210. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIX?
Across 17 cleared submissions the average was 179 days from receipt to decision (median 147).
Which companies have the most LIX clearances?
Laerdal Medical AS (3); Credo (1); Avantech, Inc. (1); Physio-Control, Inc. (1); Laerdal Medical A/S (1).
Have LIX devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2018-01-29.
Next steps
- Run an FDA pathway report with predicate devices for product code LIX
- Run a recall and safety report across every LIX manufacturer
- Watch product code LIX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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