# FMF: Syringe, Piston

- Device class: 2; regulation: 21 CFR 880.5860; FDA's rule: 510(k) required
- FDA decisions: 756
- 510(k) review time 2021–2025: median 178 days (middle half 100–267)
- Recalls: 112 (19 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: 13
- 2018: 8
- 2019: 11
- 2020: 15
- 2021: 20
- 2022: 24
- 2023: 22
- 2024: 14
- 2025: 13
- 2026: 9

## Most-cited predicates
- K980987: Becton Dickinson Syringe (1998), cited by 18
- K024112: BD Insulin Syringe (2003), cited by 11
- K110771: BD Single Use, Hypodermic Syringe (2011), cited by 9
- K980580: Becton Dickinson Syringes (1998), cited by 9
- K941657: BD Micro Fine, Ultra Fine, and Allergy Syringe (1994), cited by 8
- K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use (2019), cited by 8
- K030208: Imbibe II Syringe (2003), cited by 7
- K170675: Graftgun Universal Graft Delivery System (2017), cited by 7
- K944355: Nipro Branded Disposable Syringes, Needles (1994), cited by 6
- K771205: Hypodermic Syringe (1977), cited by 6

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