510(k) · Cleared
Recalled · Class II · 2018Aim-V (R) Medium, Model 087-0112
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invitrogen Corporation · NDS Media, Culture, Ex Vivo, Tissue And Cell
Cleared on Dec 23, 2002 as substantially equivalent to DEN000008 (Life Technologies, Inc., 2001) after a 179-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it. It has been recalled once.
- Decided
- Dec 23, 2002
- Review
- 179 days
- Class
- Class II
- Product code
- NDS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN000008 (2001). 7 later devices descend from it, 4 citing it directly.
- Root · 1 generation backDEN000008 Dulbecco's Modified Eagle Medium (Dmem)Life Technologies, Inc. · 2001
- This deviceK022086 Aim-V (R) Medium, Model 087-0112Invitrogen Corporation · 2002
- Descendant · cites it directly · 3 of its ownK100616 Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618Life Technologies Corporation · 2010
- Descendant · cites it directly · 1 of its ownK201789 CT-StorEnergy Delivery Solutions · 2021
- Descendant · 2 generations on · 1 of its ownK103302 Stempro MSC SFMLife Technologies Corporation · 2011 · Recalled
- Descendant · 3 generations on · 0 of its ownK232543 MSC SFMYocon Biology Technology Company · 2024
- Descendant · 2 generations on · 0 of its ownK240247 “MoFi” Cell Culture Basal MediumDuogenic Stemcells Corporation · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K100616Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618Life Technologies Corporation · 2010 · cites it directly3descendants
- K201789CT-StorEnergy Delivery Solutions · 2021 · cites it directly1descendant
- K103302Stempro MSC SFMLife Technologies Corporation · 2011 · 2 generations on1descendant
- K232543MSC SFMYocon Biology Technology Company · 2024 · 3 generations on0descendants
- K240247“MoFi” Cell Culture Basal MediumDuogenic Stemcells Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN000008 | Dulbecco's Modified Eagle Medium (Dmem) | Life Technologies, Inc. | 2001 | — |
| 0 (this device) | K022086 | Aim-V (R) Medium, Model 087-0112 | Invitrogen Corporation | 2002 | — |
| +1 | K100616 | Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618 | Life Technologies Corporation | 2010 | — |
| +1 | K201789 | CT-Stor | Energy Delivery Solutions | 2021 | — |
| +2 | K103302 | Stempro MSC SFM | Life Technologies Corporation | 2011 | 1 |
| +3 | K232543 | MSC SFM | Yocon Biology Technology Company | 2024 | — |
| +2 | K240247 | “MoFi” Cell Culture Basal Medium | Duogenic Stemcells Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | DEN000008 | Dulbecco's Modified Eagle Medium (Dmem) Our reading of the summary gave K001447, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN000008, Dulbecco's Modified Eagle Medium (Dmem) (Life Technologies, Inc.), granted Feb 16, 2001; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2001 |
What descends from it? (7)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 10, 2018 | Class II | Z-2543-2018 | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K100616 (Life Technologies Corporation, 2010) has gone furthest, with 3 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 | — |
What is it indicated for?
AIM-V@ is a liquid tissue culture media product intended for human ex vivo tissue and
cell culture processing applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022086: Aim-V (R) Medium, Model 087-0112.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022086
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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