510(k) · Cleared
ClearedMSC SFM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Yocon Biology Technology Company · NDS Media, Culture, Ex Vivo, Tissue And Cell
Cleared on Sep 6, 2024 as substantially equivalent to K103302 (Life Technologies Corporation, 2011) after a 381-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Sep 6, 2024
- Review
- 381 days
- Class
- Class II
- Product code
- NDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN000008 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backDEN000008 Dulbecco's Modified Eagle Medium (Dmem)Life Technologies, Inc. · 2001
- 3 generations backK022086 Aim-V (R) Medium, Model 087-0112Invitrogen Corporation · 2002 · Recalled
- 2 generations backK100616 Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618Life Technologies Corporation · 2010
- 1 generation backK103302 Stempro MSC SFMLife Technologies Corporation · 2011 · Recalled
- This deviceK232543 MSC SFMYocon Biology Technology Company · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN000008 | Dulbecco's Modified Eagle Medium (Dmem) | Life Technologies, Inc. | 2001 | — |
| −3 | 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 | — |
| −1 | K103302 | Stempro MSC SFM | Life Technologies Corporation | 2011 | 1 |
| 0 (this device) | K232543 | MSC SFM | Yocon Biology Technology Company | 2024 | — |
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 K240247 “MoFi” Cell Culture Basal Mediumscore 8.3 · 3 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 |
|---|---|---|---|
| * | K103302 | Stempro MSC SFMSummary page 5…vo Tissue And Cell Culture Processing Applications Regulation Class: II Product Code: NDS Predicate Device (K103302) Trade/Device Name: StemPro MSC SFM Medium Device Common Name: StemPro MSC SFM Manufacturer… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- 2 of the 4 ancestors have a recall of any class.
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. 2024, 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?
MSC SFM is a liquid tissue culture medium 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/K232543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232543: MSC SFM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232543
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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