510(k) · Decided
DecidedPureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emcyte Corporation · JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Cleared on May 30, 2019 after a 192-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 30, 2019
- Review
- 192 days
- Class
- Class I
- Product code
- JQC
- Recalls
- None
- 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)
No FDA recall names this device.
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. 2019, 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 PureBMC SupraPhysiologic Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet concentrate and cell concentrate from a small sample of bone marrow aspirate. The safety and effectiveness of this device for in vivo indications for use has not been established.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K183205 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183205: PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183205
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026