510(k) · Cleared
ClearedAxp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermogenesis Corp. · JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Cleared on Jul 10, 2008 as substantially equivalent to K052925 (Harvest Technologies, Corp., 2006) after a 57-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Jul 10, 2008
- Review
- 57 days
- Class
- Class I
- Product code
- JQC
- 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.
- Root · 2 generations backK991430 Smartprep Centrifuge SystemHarvest Technologies, LLC · 1999 · Recalled
- 1 generation backK052925 SMARTPREP2 Centrifuge SystemHarvest Technologies, Corp. · 2006 · Recalled
- This deviceK081345 Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139…Thermogenesis Corp. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K991430 | Smartprep Centrifuge System | Harvest Technologies, LLC | 1999 | 2 |
| −1 | K052925 | SMARTPREP2 Centrifuge System | Harvest Technologies, Corp. | 2006 | 2 |
| 0 (this device) | K081345 | Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary) | Thermogenesis Corp. | 2008 | — |
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 |
|---|---|---|---|
| * | K052925 | SMARTPREP2 Centrifuge SystemSummary page 4…beled or Promoted for a Specific Medical Use (21 CFR 862.2050) PREDICATE DEVICE: Harvest Technologies SmartPReP2 System (K052925) DEVICE DESCRIPTION The AXP Platform MarrowXpress System is a semi-automated, closed system that harvests a precise, operator-d… | 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 9 years and passes through 3 companies; a new generation was cleared every 6.6 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 JQC devicesJQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 AXP Platform MarrowXpress System is intended to be used in the clinical laboratory or intraoperatively at the point of care for preparation of a cell concentrate from bone marrow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081345 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081345: Axp Platform Marrow Xpress System Model 8-5137, 8-5138, 8-5139, 8-5140 (Primary).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081345
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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