510(k) · Cleared
Cleared3I Model (S)7426 and 7427 Celsep Centrifuge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Innovations, Inc. · JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Cleared on Feb 1, 2000 after a 55-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Feb 1, 2000
- Review
- 55 days
- Class
- Class I
- Product code
- JQC
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK994148 3I Model (S)7426 and 7427 Celsep Centrifuge SystemImplant Innovations, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK021927 Platelet Concentrate Separation Kit for Celsep Centrifuge SystemBiomet, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK030340 Autologel Process Centrifuge, Model B4360 (100-103, 100-129)Cytomedix · 2003
- Descendant · 2 generations on · 0 of its ownK030555 GPS Platelet Separation Kit with Anticoagulant Acd-aBiomet, Inc. · 2003
Most influential descendants
Showing 3 of 3 · See all- K021927Platelet Concentrate Separation Kit for Celsep Centrifuge SystemBiomet, Inc. · 2002 · cites it directly1descendant
- K030340Autologel Process Centrifuge, Model B4360 (100-103, 100-129)Cytomedix · 2003 · cites it directly0descendants
- K030555GPS Platelet Separation Kit with Anticoagulant Acd-aBiomet, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994148 | 3I Model (S)7426 and 7427 Celsep Centrifuge System | Implant Innovations, Inc. | 2000 | — |
| +1 | K021927 | Platelet Concentrate Separation Kit for Celsep Centrifuge System | Biomet, Inc. | 2002 | — |
| +1 | K030340 | Autologel Process Centrifuge, Model B4360 (100-103, 100-129) | Cytomedix | 2003 | — |
| +2 | K030555 | GPS Platelet Separation Kit with Anticoagulant Acd-a | Biomet, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K021927 (Biomet, Inc., 2002) has gone furthest, with 1 descendant 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 3i “CelSep” Centrifuge System, is designed for use in the clinical laboratory or intra-operatively at point-of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60ml) of whole 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/K994148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994148: 3I Model (S)7426 and 7427 Celsep 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/K994148
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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