FDA product code · Anesthesiology
Cardiopulmonary Resuscitation Aid Kit
0 FDA decisions. No recall names this code.
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OEV 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 · OEV
FDA has decided no OEV device since 2007.
Median 510(k) review, days · OEV
Too few OEV 510(k)s in any year since 2007 to give a median.
Recalls per year · OEV
No recall names OEV since 2007.
Adverse event reports per year · OEV
33in 2025
MAUDE reports naming product code OEV, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 49 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 23 |
| 2025 | 0 | — | 0 | 33 |
| 2026 | 0 | — | 0 | — |
Planning a device in OEV? 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 868.5915.