# EJI: Syringe, Cartridge

- Device class: 2; regulation: 21 CFR 872.6770; FDA's rule: 510(k) exempt
- FDA decisions: 45
- 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)
- 2000: 3
- 2003: 2
- 2004: 1
- 2005: 1
- 2006: 1
- 2008: 1
- 2009: 3
- 2012: 2
- 2014: 1
- 2017: 1

## Most-cited predicates
- K851903: Astra Lightweight Stainless Steel Self Aspir/Syrin (1985), cited by 3
- K961648: The Wand (1996), cited by 2
- K983105: CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge Holder (Replacements), Model # CCS-100-01 (1999), cited by 2
- K040671: Eroject, Miniject, Self Aspirating Syringes, Aspirating Syringes, Non Aspirating Syringes (2004), cited by 2
- K823536: Intralig (1982), cited by 2
- K083796: Miltex Aspirating Syringe, Miltex Petite Aspirating Syringe, Miltex Self-Aspirating Syringe, Miltex Lightweight (2009), cited by 2
- K022959: Safestep Safety Dental Cartridge Injector, Model 33-00000-1 (2003), cited by 1
- K991888: Miniject (1999), cited by 1
- K002387: Comfort Control Syringe System (2000), cited by 1
- K962999: Safety Injection System (1997), cited by 1

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