FDA product code · Cardiovascular
Aid, Cardiopulmonary Resuscitation
17 FDA decisions since 1984. 510(k) reviews decided 2021–2025 took a median of 268 days (half between 268 and 268). 2 recalls name this code, 0 of them Class I. The most-cited predicate is K071321, named by 5 later devices.
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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of LIX at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · LIX
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LIX
Too few LIX 510(k)s in any year since 2007 to give a median.
Recalls per year · LIX
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LIX
7in 2025
MAUDE reports naming product code LIX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 9 |
| 2013 | 2 | — | 0 | 50 |
| 2014 | 0 | — | 0 | 55 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 2 | — | 2 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
Planning a device in LIX? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 870.5210.