# MEG: Syringe, Antistick

- Device class: 2; regulation: 21 CFR 880.5860; FDA's rule: 510(k) required
- FDA decisions: 163
- 510(k) review time 2021–2025: median 206 days (middle half 172–292)
- Recalls: 13 (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)
- 2016: 3
- 2017: 3
- 2018: 1
- 2019: 4
- 2020: 4
- 2021: 5
- 2022: 13
- 2023: 5
- 2025: 1
- 2026: 1

## Most-cited predicates
- K072739: Jierui Syringes and Needles (2008), cited by 11
- K180417: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use (2018), cited by 8
- K022806: Duopro Safety Syringe (Duopross) (2002), cited by 6
- K092430: 1 ML Fixed Needle, 3 ML Luer Lock, 5 ML Luer Lock, 10 ML Luer Lock, 20 ML Luerl Lock Safety Syringes (2009), cited by 6
- K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle (2020), cited by 6
- K170651: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (2017), cited by 6
- K022278: TMD Safety Syringe (FA12 Series 3ML/FA13 Series 5ML) (2002), cited by 5
- K946219: Pop-N-Lok Syringe (1995), cited by 5
- K031163: Sez Safety Syringe (2003), cited by 4
- K980069: Vanishpoint Syringe (1998), cited by 4

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