510(k) · Cleared
ClearedKnockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Technologies Corporation · NDS Media, Culture, Ex Vivo, Tissue And Cell
Cleared on May 20, 2010 as substantially equivalent to K022086 (Invitrogen Corporation, 2002) after a 77-day review. Its family tree reaches back 2 generations to 2001. 3 later devices descend from it.
- Decided
- May 20, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- NDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN000008 (2001). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN000008 Dulbecco's Modified Eagle Medium (Dmem)Life Technologies, Inc. · 2001
- 1 generation backK022086 Aim-V (R) Medium, Model 087-0112Invitrogen Corporation · 2002 · Recalled
- This deviceK100616 Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618Life Technologies Corporation · 2010
- Descendant · cites it directly · 1 of its ownK103302 Stempro MSC SFMLife Technologies Corporation · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK232543 MSC SFMYocon Biology Technology Company · 2024
- Descendant · cites it directly · 0 of its ownK240247 “MoFi” Cell Culture Basal MediumDuogenic Stemcells Corporation · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN000008 | Dulbecco's Modified Eagle Medium (Dmem) | Life Technologies, Inc. | 2001 | — |
| −1 | K022086 | Aim-V (R) Medium, Model 087-0112 | Invitrogen Corporation | 2002 | 1 |
| 0 (this device) | K100616 | Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618 | Life Technologies Corporation | 2010 | — |
| +1 | K103302 | Stempro MSC SFM | Life Technologies Corporation | 2011 | 1 |
| +2 | K232543 | MSC SFM | Yocon Biology Technology Company | 2024 | — |
| +1 | K240247 | “MoFi” Cell Culture Basal Medium | Duogenic Stemcells Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022086 | Aim-V (R) Medium, Model 087-0112Summary page 1…ice: Trade Name Manufacturer 51 0(k) AIM-V® Medium Life Technologies Corporation K(022086 (formerly Invitrogen Corporation) Intended Use KnockoUtTm SR Medium and KnockoutTM SR Xenofree M… | 2002 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K103302 (Life Technologies Corporation, 2011) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K022086.
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. 2010, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Knockout™ SR Medium and Knockout™ SR Xenofree Medium are liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100616: Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100616
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026