# NDS: Media, Culture, Ex Vivo, Tissue And Cell

- Device class: 2; regulation: 21 CFR 876.5885; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 273 days (middle half 159–398)
- Recalls: 1 (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)
- 2001: 1
- 2002: 1
- 2010: 1
- 2011: 1
- 2012: 1
- 2021: 1
- 2023: 1
- 2024: 2

## Most-cited predicates
- K022086: Aim-V (R) Medium, Model 087-0112 (2002), cited by 4
- K100616: Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618 (2010), cited by 2
- DEN000008: Dulbecco's Modified Eagle Medium (Dmem) (2001), cited by 1
- K201789: CT-Stor (2021), cited by 1
- K103302: Stempro MSC SFM (2011), cited by 1

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