# SCL: Allergen And Vaccine Delivery Needles

- Device class: 2; regulation: 21 CFR 880.5570; FDA's rule: 510(k) required
- FDA decisions: 25
- 510(k) review time 2021–2025: median 120 days (middle half 120–120)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1998: 1
- 2000: 2
- 2001: 2
- 2002: 2
- 2003: 2
- 2017: 1
- 2018: 1
- 2019: 1
- 2022: 1
- 2026: 1

## Most-cited predicates
- K961918: Multi-Test II (1996), cited by 2
- K003195: Greertrack Skin Testing System, Model GT-IT, GT-IC (2000), cited by 1
- K012515: Bifurcated Vaccinating Needle (2001), cited by 1
- K020523: BD Bifurcated Needle, Models 301754, 301755, 301756, 301757 (2002), cited by 1
- K182582: Oryum and Ovem Epidermal Deri Prick Test Applicator (2019), cited by 1

Source page: https://510kreport.com/product-code/SCL
Data by year (CSV): https://510kreport.com/product-code/SCL.csv