510(k) · Cleared
Recalled · Class II · 2019Microtainer Brand Tube with Edta
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Sep 28, 1993 after a 195-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 28, 1993
- Review
- 195 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK931368 Microtainer Brand Tube with EdtaBd Becton Dickinson Vacutainer Systems Preanalytic · 1993
- Descendant · cites it directly · 2 of its ownK991702 Microtainer Brand Chemistry Tubes with Microgard Closure, Model…Becton Dickinson Vacutainer Systems · 1999 · Recalled
- Descendant · 2 generations on · 1 of its ownK230391 BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™…Becton, Dickinson and Company · 2023
- Descendant · 3 generations on · 0 of its ownK252378 BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™…Becton, Dickinson and Company · 2026
- Descendant · cites it directly · 0 of its ownK983517 Safe-T-Fill Capillary Blood Collection SystemRam Scientific · 1998 · Recalled
- Descendant · cites it directly · 0 of its ownK981973 Safe-T-Fill Capillary Blood Collection SystemRam Scientific · 1998 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K991702Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963…Becton Dickinson Vacutainer Systems · 1999 · cites it directly2descendants
- K230391BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood…Becton, Dickinson and Company · 2023 · 2 generations on1descendant
- K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood…Becton, Dickinson and Company · 2026 · 3 generations on0descendants
- K983517Safe-T-Fill Capillary Blood Collection SystemRam Scientific · 1998 · cites it directly0descendants
- K981973Safe-T-Fill Capillary Blood Collection SystemRam Scientific · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931368 | Microtainer Brand Tube with Edta | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993 | — |
| +1 | K991702 | Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965… | Becton Dickinson Vacutainer Systems | 1999 | 9 |
| +2 | K230391 | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™… | Becton, Dickinson and Company | 2023 | — |
| +3 | K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™… | Becton, Dickinson and Company | 2026 | — |
| +1 | K983517 | Safe-T-Fill Capillary Blood Collection System | Ram Scientific | 1998 | 11 |
| +1 | K981973 | Safe-T-Fill Capillary Blood Collection System | Ram Scientific | 1998 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 3, 2019 | Class II | Z-1967-2019 | Under Investigation by firm | The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A… |
| Aug 20, 2004 | Not classified | Z-1603-05 | Other | "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991702 (Becton Dickinson Vacutainer Systems, 1999) 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 | — |
https://510kreport.com/device/K931368 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931368: Microtainer Brand Tube with Edta.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931368
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026