510(k) · Cleared
Recalled · Class I · 2018BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Sep 23, 2016 as substantially equivalent to K954592 (Becton Dickinson Vacutainer Systems, 1995) after a 199-day review. Its family tree reaches back 1 generation to 1995. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- Sep 23, 2016
- Review
- 199 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 2 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954592 (1995). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK954592 Vacutainer Brand PST Plasma Separation TubeBecton Dickinson Vacutainer Systems · 1995 · Recalled
- This deviceK160657 BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection TubeBecton, Dickinson and Company · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954592 | Vacutainer Brand PST Plasma Separation Tube | Becton Dickinson Vacutainer Systems | 1995 | 1 |
| 0 (this device) | K160657 | BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube | Becton, Dickinson and Company | 2016 | — |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K954592 | Vacutainer Brand PST Plasma Separation TubeSummary page 6…ICE KEY PARAMETERS PROPOSED DEVICE (K954592) PRODUCT NAME BD Barricor™ Tube BD PST™ Tube… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 22, 2018 | Class I | Z-1142-2018 | Device Design | BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCare assays, employing the Anodic… |
| Sep 18, 2017 | Class II | Z-1180-2018 | Nonconforming Material/Component | Increased amount of residual blood present on the top of stopper well after venipuncture |
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 JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
BD Vacutainer® Barricor™ Lithium Heparin Plasma Blood Collection Tubes (BD Barricor™ Tubes) are used to collect,
separate, process, transport, and store venous blood samples for use in chemistry determinations, therapeutic drug
monitoring, and zinc testing in plasma for in vitro diagnostic use. It is used in settings where a venous blood sample is
collected by a trained healthcare worker.
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/K160657 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160657: BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160657
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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