FDA product code · Anesthesiology
Epidural Anesthesia Kit
0 FDA decisions. 27 recalls name this code, 1 of them Class I.
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 kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of OGE 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 · OGE
FDA has decided no OGE device since 2007.
Median 510(k) review, days · OGE
Too few OGE 510(k)s in any year since 2007 to give a median.
Recalls per year · OGE
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OGE
97in 2025
MAUDE reports naming product code OGE, 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 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 33 |
| 2015 | 0 | — | 0 | 96 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 0 | — | 3 | 65 |
| 2018 | 0 | — | 0 | 80 |
| 2019 | 0 | — | 0 | 341 |
| 2020 | 0 | — | 0 | 76 |
| 2021 | 0 | — | 0 | 41 |
| 2022 | 0 | — | 2 | 77 |
| 2023 | 0 | — | 0 | 63 |
| 2024 | 0 | — | 1 | 102 |
| 2025 | 0 | — | 13 | 97 |
| 2026 | 0 | — | 8 (1) | — |
Planning a device in OGE? 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 868.5120.