510(k) · Cleared
Recalled · Class II · 2017Smartprep Centrifuge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harvest Technologies, LLC · JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Cleared on May 28, 1999 after a 32-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- May 28, 1999
- Review
- 32 days
- Class
- Class I
- Product code
- JQC
- Recalls
- 2
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK991430 Smartprep Centrifuge SystemHarvest Technologies, LLC · 1999
- Descendant · cites it directly · 3 of its ownK052925 SMARTPREP2 Centrifuge SystemHarvest Technologies, Corp. · 2006 · Recalled
- Descendant · cites it directly · 1 of its ownK021902 Magellan Autologus Platelet Separator, MAG100, Magellan Autologous…Medtronic Vascular · 2002
- Descendant · 2 generations on · 0 of its ownK250518 SMART M-CELL Bone Marrow Concentration SystemMiracell Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK250516 SMART M-CELL PRP Concentration SystemMiracell Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK081345 Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139…Thermogenesis Corp. · 2008
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K052925SMARTPREP2 Centrifuge SystemHarvest Technologies, Corp. · 2006 · cites it directly3descendants
- K021902Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator…Medtronic Vascular · 2002 · cites it directly1descendant
- K250518SMART M-CELL Bone Marrow Concentration SystemMiracell Co., Ltd. · 2026 · 2 generations on0descendants
- K250516SMART M-CELL PRP Concentration SystemMiracell Co., Ltd. · 2026 · 2 generations on0descendants
- K081345Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)Thermogenesis Corp. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991430 | Smartprep Centrifuge System | Harvest Technologies, LLC | 1999 | — |
| +1 | K052925 | SMARTPREP2 Centrifuge System | Harvest Technologies, Corp. | 2006 | 2 |
| +1 | K021902 | Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet… | Medtronic Vascular | 2002 | — |
| +2 | K250518 | SMART M-CELL Bone Marrow Concentration System | Miracell Co., Ltd. | 2026 | — |
| +2 | K250516 | SMART M-CELL PRP Concentration System | Miracell Co., Ltd. | 2026 | — |
| +2 | K081345 | Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary) | Thermogenesis Corp. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2026 | 2 | 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 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? (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 |
|---|---|---|---|
| * | — | Predicate Centrifuge Named without a submission number |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- Of its descendants, K052925 (Harvest Technologies, Corp., 2006) has gone furthest, with 3 descendants of its own.
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.
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 Harvest SmartPReP™ 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.
The plasma and concentrated platelets produced can be used for diagnostic tests.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991430: Smartprep Centrifuge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991430
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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