De Novo · Granted
GrantedDulbecco's Modified Eagle Medium (Dmem)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Technologies, Inc. · NDS Media, Culture, Ex Vivo, Tissue And Cell
Granted on Feb 16, 2001 as a new device type through De Novo after a 59-day review. 8 later devices descend from it.
- Decided
- Feb 16, 2001
- Review
- 59 days
- Class
- Class II
- Product code
- NDS
- Recalls
- None
8 later devices descend from it, 1 citing it directly.
- This deviceDEN000008 Dulbecco's Modified Eagle Medium (Dmem)Life Technologies, Inc. · 2001
- Descendant · cites it directly · 7 of its ownK022086 Aim-V (R) Medium, Model 087-0112Invitrogen Corporation · 2002 · Recalled
- Descendant · 2 generations on · 3 of its ownK100616 Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618Life Technologies Corporation · 2010
- Descendant · 2 generations on · 1 of its ownK201789 CT-StorEnergy Delivery Solutions · 2021
- Descendant · 3 generations on · 1 of its ownK103302 Stempro MSC SFMLife Technologies Corporation · 2011 · Recalled
- Descendant · 4 generations on · 0 of its ownK232543 MSC SFMYocon Biology Technology Company · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K022086Aim-V (R) Medium, Model 087-0112Invitrogen Corporation · 2002 · cites it directly7descendants
- K100616Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618Life Technologies Corporation · 2010 · 2 generations on3descendants
- K201789CT-StorEnergy Delivery Solutions · 2021 · 2 generations on1descendant
- K103302Stempro MSC SFMLife Technologies Corporation · 2011 · 3 generations on1descendant
- K232543MSC SFMYocon Biology Technology Company · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN000008 | Dulbecco's Modified Eagle Medium (Dmem) | Life Technologies, Inc. | 2001 | — |
| +1 | K022086 | Aim-V (R) Medium, Model 087-0112 | Invitrogen Corporation | 2002 | 1 |
| +2 | K100616 | Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618 | Life Technologies Corporation | 2010 | — |
| +2 | K201789 | CT-Stor | Energy Delivery Solutions | 2021 | — |
| +3 | K103302 | Stempro MSC SFM | Life Technologies Corporation | 2011 | 1 |
| +4 | K232543 | MSC SFM | Yocon Biology Technology Company | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NDS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NDS device
- #1 K232543 MSC SFMscore 8.9 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022086 | Aim-V (R) Medium, Model 087-0112 | 2002 | 7 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022086 (Invitrogen Corporation, 2002) has gone furthest, with 7 descendants of its own.
How does its category compare?
All NDS devicesNDS Media, Culture, Ex Vivo, Tissue And Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NDS
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NDS
Too few NDS 510(k)s in any year since 2007 to give a median.
Recalls per year · NDS
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDS
No MAUDE report names NDS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN000008 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN000008: Dulbecco's Modified Eagle Medium (Dmem).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN000008
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026