# FMI: Needle, Hypodermic, Single Lumen

- Device class: 2; regulation: 21 CFR 880.5570; FDA's rule: 510(k) required
- FDA decisions: 696
- 510(k) review time 2021–2025: median 144 days (middle half 87–222)
- Recalls: 231 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 9
- 2018: 20
- 2019: 12
- 2020: 11
- 2021: 18
- 2022: 23
- 2023: 18
- 2024: 3
- 2025: 11
- 2026: 12

## Most-cited predicates
- K051899: BD Pen Needle (2005), cited by 14
- K100005: BD Pen Needle (2010), cited by 10
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe (1996), cited by 10
- K070440: BD Hypoint Needle (2007), cited by 8
- K771203: Disp. Hypodermic Needle (1977), cited by 8
- K032885: Vidaport Intraosseous Infusion System (2004), cited by 8
- K982541: Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608 (1998), cited by 8
- K951254: Safetyglide Needle (1995), cited by 8
- K113422: Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle (2012), cited by 8
- K080904: Feel-Fine Insulin Pen Needle (2008), cited by 8

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