510(k) · Cleared
Recalled · 2010Immunicon Celltracks Autoprep System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunicon Corp. · GKH Apparatus, Automated Blood Cell Diluting
Cleared on Mar 12, 2004 after a 58-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Mar 12, 2004
- Review
- 58 days
- Class
- Class I
- Product code
- GKH
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK040077 Immunicon Celltracks Autoprep SystemImmunicon Corp. · 2004
- Descendant · cites it directly · 0 of its ownK100684 Celltracks Autoprep System Model:9541Veridex, LLC · 2010
Most influential descendants
Showing 1 of 1 · See all- K100684Celltracks Autoprep System Model:9541Veridex, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040077 | Immunicon Celltracks Autoprep System | Immunicon Corp. | 2004 | — |
| +1 | K100684 | Celltracks Autoprep System Model:9541 | Veridex, LLC | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 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 |
|---|---|---|---|
| * | — | Immunicon CellPrep Sample Preparation system Named without a submission number |
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 |
|---|---|---|---|
| K100684 | Celltracks Autoprep System Model:9541 | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2010 | Not classified | Z-2175-2010 | Process control | Complaints of patient sample carryover. |
| May 6, 2009 | Not classified | Z-1734-2009 | Device Design | Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K100684 (Veridex, LLC, 2010) has gone furthest, with 0 descendants of its own.
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 intended use for the Immunicon CellTracks™ AutoPrep System is as a general-purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. Cell analyzers such as the CellTracks™ Analyzer, CellSpotter™ System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040077 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040077: Immunicon Celltracks Autoprep System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040077
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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