510(k) · Cleared
Recalled · 2009Marrowstim Concentration Kit and Marrowstim Mini Concentration Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Cleared on Oct 11, 2007 after a 90-day review. The FDA summary names no predicate by number. It has been recalled once.
- Decided
- Oct 11, 2007
- Review
- 90 days
- Class
- Class I
- Product code
- JQC
- Recalls
- 1
- Predicates
- 0
The FDA summary names no predicate by number.
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 JQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2009 | Not classified | Z-1207-2009 | Process control | A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All JQC devicesJQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JQC
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JQC
Too few JQC 510(k)s in any year since 2007 to give a median.
Recalls per year · JQC
3in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JQC
6in 2025
MAUDE reports naming product code JQC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 6 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 1 | — | 2 | 7 |
| 2011 | 0 | — | 1 | 40 |
| 2012 | 0 | — | 0 | 18 |
| 2013 | 0 | — | 0 | 26 |
| 2014 | 0 | — | 1 | 112 |
| 2015 | 0 | — | 0 | 130 |
| 2016 | 0 | — | 0 | 70 |
| 2017 | 0 | — | 2 | 31 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 1 | — | 3 | 7 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The MarrowStimTM Concentration Kit and the MarrowStimTM Mini Concentration Kit are intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071934 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071934: Marrowstim Concentration Kit and Marrowstim Mini Concentration Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071934
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026