# DEN000008: Dulbecco's Modified Eagle Medium (Dmem)

- Pathway: De Novo (Post-NSE)
- Applicant: Life Technologies, Inc.
- Decided: Feb 16, 2001 after 59 days
- Product code: NDS (Media, Culture, Ex Vivo, Tissue And Cell)
- Device class: 2
- Regulation: 21 CFR 876.5885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K022086: Aim-V (R) Medium, Model 087-0112 (2002), 7 descendants of its own
- K100616: Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618 (2010), 3 descendants of its own
- K201789: CT-Stor (2021), 1 descendant of its own
- K103302: Stempro MSC SFM (2011), 1 descendant of its own
- K232543: MSC SFM (2024), 0 descendants of its own

Source page: https://510kreport.com/device/DEN000008
Methodology: https://510kreport.com/methodology