510(k) · Cleared
ClearedCoulter Cellprep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · GKH Apparatus, Automated Blood Cell Diluting
Cleared on Jun 11, 2002 after a 62-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 11, 2002
- Review
- 62 days
- Class
- Class I
- Product code
- GKH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 GKH? 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 |
|---|---|---|---|
| * | — | COULTER Multi-Q-Prep Named without a submission number |
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 GKH devicesGKH Apparatus, Automated Blood Cell Diluting: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKH
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · GKH
Too few GKH 510(k)s in any year since 2007 to give a median.
Recalls per year · GKH
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKH
2in 2009
MAUDE reports naming product code GKH, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 2 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The COULTER@CellPrep is an automated system that processes human blood for preparation of leukocyte suspensions for quantitative immunofluorescence analysis by optical flow cytometers.
The use of data generated by this instrument depends on the regulatory status of the reagents you use. If the reagent is labeled by the manufacturer “For Research Use Onty. Not for use in diagnostic procedures,” federal law prohibits the use of the data for diagnosis.
This product is intended “For In Vitro Diagnostic Use” when using the “IVDImmunophenotype”protocol and processing whole blood samples with COULTER reagents and antibodies labeled for In Vitro Diagnostic Use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021150 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021150: Coulter Cellprep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021150
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026