FDA product code · General hospital
Allergen And Vaccine Delivery Needles
25 FDA decisions since 1976. 510(k) reviews decided 2021–2025 took a median of 120 days (half between 120 and 120). No recall names this code. The most-cited predicate is K961918, named by 2 later devices.
An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of SCL 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 · SCL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · SCL
Too few SCL 510(k)s in any year since 2007 to give a median.
Recalls per year · SCL
No recall names SCL since 2007.
Adverse event reports per year · SCL
No MAUDE report names SCL since 2007.
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 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
Planning a device in SCL? 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 880.5570.