510(k) · Cleared
ClearedCobe Angel Whole Blood Separation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cobe Cardiovascular, Inc. · JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Cleared on Nov 19, 2004 as substantially equivalent to K021902 (Medtronic Vascular, 2002) after a 67-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Nov 19, 2004
- Review
- 67 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 backK021902 Magellan Autologus Platelet Separator, MAG100, Magellan Autologous…Medtronic Vascular · 2002
- This deviceK042473 Cobe Angel Whole Blood Separation SystemCobe Cardiovascular, Inc. · 2004
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 | K021902 | Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet… | Medtronic Vascular | 2002 | — |
| 0 (this device) | K042473 | Cobe Angel Whole Blood Separation System | Cobe Cardiovascular, Inc. | 2004 | — |
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 |
|---|---|---|---|
| * | K021902 | Magellan Autologus Platelet Separator, MAG100, Magellan Autologous Platelet Separator…Summary page 1…r a Specific Medical Use (21 CFR 862.2050) PREDICATE DEVICE: Medtronic Magellan MT Autologous Platelet Separator System (K021902) DEVICE DESCRIPTION: The COBE® Angel Whole Blood Separation System consists of a blood centrifugation device and associated dispo… | 2002 |
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 5 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
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 COBE® Angel Whole Blood Separation System is intended to be used at the patient's point-of-care for the safe and rapid preparation of platelet poor plasma and platelet rich plasma from a sample of whole blood.
The plasma and concentrated platelets can be used for diagnostic tests.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042473 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042473: Cobe Angel Whole Blood Separation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042473
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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