# MMK: Container, Sharps

- Device class: 2; regulation: 21 CFR 880.5570; FDA's rule: 510(k) required
- FDA decisions: 114
- 510(k) review time 2021–2025: median 138 days (middle half 115–262)
- Recalls: 3 (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)
- 2016: 4
- 2017: 1
- 2018: 1
- 2019: 4
- 2020: 1
- 2021: 3
- 2022: 1
- 2023: 3
- 2025: 3
- 2026: 2

## Most-cited predicates
- K980490: Sage Products Inc, Sharps Disposal Containers with Screw Top Caps (1998), cited by 4
- K190240: Tiger Sharps Containers (2019), cited by 4
- K130281: Oak Ridge Products Sharp Container (2013), cited by 4
- K964387: Point of Use II Sharps-a-Gator (1997), cited by 3
- K072667: Sharps Away Disposable Container (2007), cited by 3
- K943659: Ancillary and Large Volume Sharps Disposal Containers (1995), cited by 2
- K955514: Sharps Safe 1.5 & Sharps Safe 2.0 (1996), cited by 2
- K982781: Demolizer #47 One-Gallon Point of Generation Sharps Container (1998), cited by 2
- K180984: Maxcon Sharps Container (2019), cited by 2
- K111085: Sharps Tank Reusable Sharps Container (2012), cited by 2

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