510(k) · Cleared
Recalled · 2011BD Microtainer Map Microtube for Automated Process, Model 363706
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jan 21, 2010 as substantially equivalent to K940905 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1994) after a 28-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 21, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940905 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK940905 Microtainer Brand Tube with Edta (K2)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1994 · Recalled
- This deviceK093972 BD Microtainer Map Microtube for Automated Process, Model 363706Becton, Dickinson & CO · 2010
- Descendant · cites it directly · 0 of its ownK230493 BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H…Becton, Dickinson and Company · 2023
- Descendant · cites it directly · 0 of its ownK182078 MiniCollect K2E K2EDTA TubesGreiner Bio-One Na, Inc. · 2019
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 | K940905 | Microtainer Brand Tube with Edta (K2) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | 2 |
| 0 (this device) | K093972 | BD Microtainer Map Microtube for Automated Process, Model 363706 | Becton, Dickinson & CO | 2010 | — |
| +1 | K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary… | Becton, Dickinson and Company | 2023 | — |
| +1 | K182078 | MiniCollect K2E K2EDTA Tubes | Greiner Bio-One Na, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K940905 | Microtainer Brand Tube with Edta (K2)Summary page 3…lso identified in the table below. Manufacturer Predicate Device K-Number Clearance Date Becton, 80 Microtain-er" K940905 August 02, 1994 Dickinson and 42EDTA tube with Company Microgard "'… | 1994 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Feb 11, 2011 | Not classified | Z-0176-2012 | Device Design | BD Microtainer MAP Microtube is being recalled due to the potential clotting of blood specimens resulting from a reduced amount of EDTA additive. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2010, 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 Microtainer MAP Microtube for Automated Process with K2EDTA is used to collect, anticoagulate, transport and store skin puncture blood specimens for measurement of the following hematological parameters: White Blood Cells (WBC), Red Blood Cells (RBC), Hemoglobin (HgB), Hematocrit (HCT), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Platelets, 5-part White Blood Cell (WBC) differentials (Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils), Reticulocytes and Whole Blood Lead testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093972: BD Microtainer Map Microtube for Automated Process, Model 363706.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093972
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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