510(k) · Cleared
ClearedBD Vacutainer® Citrate Blood Collection Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · GIM Tubes, Vacuum Sample, With Anticoagulant
Cleared on Oct 31, 2024 as substantially equivalent to K013971 (Becton, Dickinson & CO, 2002) after a 259-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Oct 31, 2024
- Review
- 259 days
- Class
- Class II
- Product code
- GIM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013971 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK013971 BD Vacutainer Safety Coagulation TubeBecton, Dickinson & CO · 2002 · Recalled
- This deviceK240455 BD Vacutainer® Citrate Blood Collection TubesBecton, Dickinson and Company · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013971 | BD Vacutainer Safety Coagulation Tube | Becton, Dickinson & CO | 2002 | 5 |
| 0 (this device) | K240455 | BD Vacutainer® Citrate Blood Collection Tubes | Becton, Dickinson and Company | 2024 | — |
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 K230493 BD MiniDraw Capillary Blood Collection System…score 6.7 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K013971 | BD Vacutainer Safety Coagulation TubeSummary page 6…Anticoagulant Classification Regulation: 21 CFR § 862.1675 Regulatory Class: Class II Product Code: GIM 1.9 Predicate Device BD Vacutainer Safety Coagulation Tube (K013971) 1.10 Device Establishment Becton, Dickinson and Company 1.11 Registration Number: 2243072 1.12 Performance Standar… | 2002 |
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?
- Its one ancestor has a recall.
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. 2024, 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?
The BD Vacutainer® Citrate Blood Collection Tube (0.109M buffered sodium citrate) is a sterile, single use tube used for the collection, containment, transport, and centrifugation of venous blood specimens to obtain plasma for in vitro diagnostic testing. It is used in settings where a venous blood sample is collected by a trained healthcare worker. The BD Vacutainer® Citrate Blood Collection Tube is used for clinical laboratory testing in coagulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240455: BD Vacutainer® Citrate 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/K240455
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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