510(k) · Cleared
ClearedMagellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator Deisposable Kit, MKT300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Vascular · JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Cleared on Aug 12, 2002 as substantially equivalent to K991430 (Harvest Technologies, LLC, 1999) after a 63-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Aug 12, 2002
- Review
- 63 days
- Class
- Class I
- Product code
- JQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991430 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK991430 Smartprep Centrifuge SystemHarvest Technologies, LLC · 1999 · Recalled
- This deviceK021902 Magellan Autologus Platelet Separator, MAG100, Magellan Autologous…Medtronic Vascular · 2002
- Descendant · cites it directly · 0 of its ownK042473 Cobe Angel Whole Blood Separation SystemCobe Cardiovascular, Inc. · 2004
Most influential descendants
Showing 1 of 1 · See all- K042473Cobe Angel Whole Blood Separation SystemCobe Cardiovascular, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991430 | Smartprep Centrifuge System | Harvest Technologies, LLC | 1999 | 2 |
| 0 (this device) | K021902 | Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet… | Medtronic Vascular | 2002 | — |
| +1 | K042473 | Cobe Angel Whole Blood Separation System | Cobe Cardiovascular, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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 |
|---|---|---|---|
| * | K991430 | Smartprep Centrifuge SystemSummary page 1…e: SmartPRePTM Centrifuge System Harvest Technologies Corp. IS991430 - 05/28/1999 Device Description: Magellan Autologous Platelet Separator system… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042473 | Cobe Angel Whole Blood Separation System | 2004 | 0 |
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?
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 Magellan™ Autologous Platelet Separator 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 (platelet rich plasma) from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021902 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021902: Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator Deisposable Kit, MKT300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021902
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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