510(k) · Cleared
Recalled · Class II · 2019Stempro MSC SFM
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 Feb 18, 2011 as substantially equivalent to K100616 (Life Technologies Corporation, 2010) after a 101-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 18, 2011
- Review
- 101 days
- Class
- Class II
- Product code
- NDS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN000008 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN000008 Dulbecco's Modified Eagle Medium (Dmem)Life Technologies, Inc. · 2001
- 2 generations backK022086 Aim-V (R) Medium, Model 087-0112Invitrogen Corporation · 2002 · Recalled
- 1 generation backK100616 Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618Life Technologies Corporation · 2010
- This deviceK103302 Stempro MSC SFMLife Technologies Corporation · 2011
- Descendant · cites it directly · 0 of its ownK232543 MSC SFMYocon Biology Technology Company · 2024
Most influential descendants
Showing 1 of 1 · See all- K232543MSC SFMYocon Biology Technology Company · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN000008 | Dulbecco's Modified Eagle Medium (Dmem) | Life Technologies, Inc. | 2001 | — |
| −2 | K022086 | Aim-V (R) Medium, Model 087-0112 | Invitrogen Corporation | 2002 | 1 |
| −1 | K100616 | Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618 | Life Technologies Corporation | 2010 | — |
| 0 (this device) | K103302 | Stempro MSC SFM | Life Technologies Corporation | 2011 | — |
| +1 | K232543 | MSC SFM | Yocon Biology Technology Company | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 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 |
|---|---|---|---|
| * | K100616 | Knockout SR Medium, Knockout SR Xenofree Medium Model 10828, 12618Summary page 1…Qctober 11, 2010 j, Predicate Device: Trade Name Manufacturer KnockoutTM SR Medium Life Technologies Corporation K100616 Intended Use StemPro® MSC SFM Medium 'isa liquid tissue culture media product intended for human ex vivo tissue and cell cultu… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232543 | MSC SFM | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2019 | Class II | Z-0274-2020 | Vendor change control | Component was not tested by the supplier for adventitious agents |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K232543 (Yocon Biology Technology Company, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K100616.
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. 2011, 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?
StemPro® MSC SFM Medium is a 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/K103302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103302: Stempro 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/K103302
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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