510(k) · Cleared
Recalled · Class II · 2017SMARTPREP2 Bmac System, Smartprep Platelet Concentration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harvest Technologies, Corp. · JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Cleared on Dec 6, 2010 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.
- Decided
- Dec 6, 2010
- Review
- 21 days
- Class
- Class I
- Product code
- JQC
- Recalls
- 2
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|---|
| Oct 20, 2017 | Class II | Z-0103-2018 | Process control | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. The… |
| Oct 20, 2017 | Class II | Z-0104-2018 | Process control | The patient labels included in the BMAC system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. The… |
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. 2010, 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 SmartPReP2 Centrifuge System is 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.
The SmartPReP1 Centrifuge System is designed 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103340: SMARTPREP2 Bmac System, Smartprep Platelet 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/K103340
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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