510(k) · Cleared
ClearedSMART M-CELL Bone Marrow Concentration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miracell Co., Ltd. · QBV Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
Cleared on Apr 2, 2026 as substantially equivalent to K052925 (Harvest Technologies, Corp., 2006) after a 405-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Apr 2, 2026
- Review
- 405 days
- Class
- Class I
- Product code
- QBV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K991430 (1999). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 QBV? 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 QBV device
- #1 K250516 SMART M-CELL PRP Concentration Systemscore 11.4 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K052925 | SMARTPREP2 Centrifuge SystemSummary page 5…Class : Class I Product Code : QBV Predicate Device : Trade/Device Name : SmartPReP2 Centrifuge System (K052925) Common Name : Syringe, Piston Regulation Number : 21 CFR 880.5860 Regulation… | 2006 |
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 27 years and passes through 3 companies; a new generation was cleared every 20.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 2 other devices also cite its predicate K052925.
How does its category compare?
All QBV devicesQBV Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QBV
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QBV
Too few QBV 510(k)s in any year since 2007 to give a median.
Recalls per year · QBV
No recall names QBV since 2007.
Adverse event reports per year · QBV
No MAUDE report names QBV 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 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 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The SMART M-CELL Bone Marrow Concentration System is intended to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of a cell concentrate from bone marrow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250518: SMART M-CELL Bone Marrow Concentration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250518
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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