510(k) · Cleared
ClearedImmunicon Cellsave Preservative Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunicon Corp. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Aug 8, 2003 after a 164-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 8, 2003
- Review
- 164 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK030596 Immunicon Cellsave Preservative TubeImmunicon Corp. · 2003
- Descendant · cites it directly · 2 of its ownK040107 Cyto-Chex BCTStreck Laboratories, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK080552 Cyto-Chex BCTStreck · 2008 · Recalled
- Descendant · 3 generations on · 0 of its ownK162723 TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030596 | Immunicon Cellsave Preservative Tube | Immunicon Corp. | 2003 | — |
| +1 | K040107 | Cyto-Chex BCT | Streck Laboratories, Inc. | 2004 | — |
| +2 | K080552 | Cyto-Chex BCT | Streck | 2008 | 1 |
| +3 | K162723 | TransFix/EDTA Vacuum Blood Collection Tubes | Caltag Medsystems, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2017 | 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 JKA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | — | Becton Dickinson Vacutainer Brand Blood Collection Tube with EDTA Anticoagulant Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040107 | Cyto-Chex BCT | 2004 | 2 |
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, K040107 (Streck Laboratories, Inc., 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, 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 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
CellSave tubes are evacuated blood collection tubes that are designed to be used with standard phlebotomy supplies for venous blood collections. The tube contains 300 μl of a solution that contains Na2EDTA and a cell preservative. The preservative preserves morphology and cell surface antigen expression of the epithelial cells and leukocytes. This tube may be used for monitoring of circulating epithelial cells (tumor cells) which may aid in the management of cancer patients. This tube may be used for monitoring CD3+/CD4+ T lymphocyte subsets which may aid in the management of patients with HIV/AIDS.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030596: Immunicon Cellsave Preservative Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030596
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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