510(k) · Cleared
ClearedCyto-Chex BCT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Streck Laboratories, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jul 27, 2004 as substantially equivalent to K030596 (Immunicon Corp., 2003) after a 189-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Jul 27, 2004
- Review
- 189 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030596 (2003). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK030596 Immunicon Cellsave Preservative TubeImmunicon Corp. · 2003
- This deviceK040107 Cyto-Chex BCTStreck Laboratories, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK080552 Cyto-Chex BCTStreck · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK162723 TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030596 | Immunicon Cellsave Preservative Tube | Immunicon Corp. | 2003 | — |
| 0 (this device) | K040107 | Cyto-Chex BCT | Streck Laboratories, Inc. | 2004 | — |
| +1 | K080552 | Cyto-Chex BCT | Streck | 2008 | 1 |
| +2 | K162723 | TransFix/EDTA Vacuum Blood Collection Tubes | Caltag Medsystems, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K030596 | Immunicon Cellsave Preservative TubeSummary page 1…me: Blood specimen collection device Classification Name: Blood specimen collection device, 210CFR862.1675 Predicate Device: Immunicon CellSaveTM, K030596 Description: Cyto-Chex BOT consists of a standard 13 x 75mm glass blood collection tube containing 57u1 of s… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080552 | Cyto-Chex BCT | 2008 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K080552 (Streck, 2008) has gone furthest, with 1 descendant 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?
Cyto-Chex® BCT is intended for the collection and storage of blood specimens for immunophenotyping of WBC by flow-cytometry. Recovery of lymphocyte subset cell markers of the HIV panel can be accomplished over a 7 day period following collection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040107 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040107: Cyto-Chex BCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040107
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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