510(k) · Cleared
ClearedPlatelet Concentrate Separation Kit for Celsep Centrifuge System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Cleared on Jul 12, 2002 as substantially equivalent to K994148 (Implant Innovations, Inc., 2000) after a 30-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jul 12, 2002
- Review
- 30 days
- Class
- Class I
- Product code
- LXG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K994148 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK994148 3I Model (S)7426 and 7427 Celsep Centrifuge SystemImplant Innovations, Inc. · 2000
- This deviceK021927 Platelet Concentrate Separation Kit for Celsep Centrifuge SystemBiomet, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK030555 GPS Platelet Separation Kit with Anticoagulant Acd-aBiomet, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K030555GPS Platelet Separation Kit with Anticoagulant Acd-aBiomet, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K994148 | 3I Model (S)7426 and 7427 Celsep Centrifuge System | Implant Innovations, Inc. | 2000 | — |
| 0 (this device) | K021927 | Platelet Concentrate Separation Kit for Celsep Centrifuge System | Biomet, Inc. | 2002 | — |
| +1 | K030555 | GPS Platelet Separation Kit with Anticoagulant Acd-a | Biomet, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 LXG? 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 |
|---|---|---|---|
| * | K994148 | 3I Model (S)7426 and 7427 Celsep Centrifuge SystemSummary page 1…rketed Devices to Which substantial Equivalence is Claimed: The modified device is substantially equivalent to the original Implant innovations CelSep@Centrifuge System (K994148) for producing,platelet rich plasma from 50-60 ml of whole blood. Device Description The platetet concentrate separation kit ai… | 2000 |
| † | K994841 | Unnamed device |
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 |
|---|---|---|---|
| K030555 | GPS Platelet Separation Kit with Anticoagulant Acd-a | 2003 | 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 LXG devicesLXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXG
FDA has decided no LXG device since 2007.
Median 510(k) review, days · LXG
Too few LXG 510(k)s in any year since 2007 to give a median.
Recalls per year · LXG
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXG
1,253in 2025
MAUDE reports naming product code LXG, 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 | 0 | — | 1 | 7 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 2 | 1 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 1 | 8 |
| 2013 | 0 | — | 0 | 21 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 9 | 25 |
| 2019 | 0 | — | 2 | 27 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 0 | — | 0 | 11 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 1,253 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Platelet Concentrate Separation kit 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 fiom a small sample (50-60 rnl) of whole blood.
The plasma and ancentrated platelets can be used for diagnostic tests.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021927 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021927: Platelet Concentrate Separation Kit for Celsep Centrifuge System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021927
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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