510(k) · Cleared
ClearedTransFix/EDTA Vacuum Blood Collection Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caltag Medsystems, Ltd. · GIM Tubes, Vacuum Sample, With Anticoagulant
Cleared on Jun 22, 2017 as substantially equivalent to K080552 (Streck, 2008) after a 266-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Jun 22, 2017
- Review
- 266 days
- Class
- Class II
- Product code
- GIM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K030596 (2003). No later device cites it as a predicate yet.
- Root · 3 generations backK030596 Immunicon Cellsave Preservative TubeImmunicon Corp. · 2003
- 2 generations backK040107 Cyto-Chex BCTStreck Laboratories, Inc. · 2004
- 1 generation backK080552 Cyto-Chex BCTStreck · 2008 · Recalled
- This deviceK162723 TransFix/EDTA Vacuum Blood Collection TubesCaltag Medsystems, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
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 GIM? 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 GIM device
- #1 K240455 BD Vacutainer® Citrate Blood Collection Tubesscore 8.3 · 1 generation · 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 |
|---|---|---|---|
| * | K080552 | Cyto-Chex BCTSummary page 4…tion of the legally marketed predicate devices Cyto-Chex® BCT (Blood Collection Tubes, Streck Laboratories, Inc., Omaha, NE), cleared under K080552 807.92 (a)(4): Device Description TransFix®/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of… | 2008 |
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.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All GIM devicesGIM Tubes, Vacuum Sample, With Anticoagulant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · GIM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GIM
Too few GIM 510(k)s in any year since 2007 to give a median.
Recalls per year · GIM
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIM
641in 2025
MAUDE reports naming product code GIM, 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 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 276 |
| 2019 | 0 | — | 0 | 145 |
| 2020 | 0 | — | 0 | 147 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 2 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 316 |
| 2025 | 0 | — | 1 | 641 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
TransFix/EDTA Vacuum Blood Collection Tubes (TVTs) are intended for collection and storage of human whole blood
specimens for immunophenotyping of white blood cells by flow cytometry. Recovery of lymphocyte subset markers of
the HIV panel can be accomplished over a 14-day period following collection.
TVTs are in-vitro diagnostic medical devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162723: TransFix/EDTA Vacuum Blood Collection Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162723
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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