510(k) · Cleared
Recalled · Class II · 2019Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963, 365967, 36578
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Vacutainer Systems · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jul 28, 1999 as substantially equivalent to K771370 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1977) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1977. 2 later devices descend from it. It has been recalled 9 times.
- Decided
- Jul 28, 1999
- Review
- 70 days
- Class
- Class II
- Product code
- JKA
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 1 generation to K771370 (1977). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK771370 Icrotaineo Brand TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1977 · Recalled
- This deviceK991702 Microtainer Brand Chemistry Tubes with Microgard Closure, Model…Becton Dickinson Vacutainer Systems · 1999
- Descendant · cites it directly · 1 of its ownK230391 BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™…Becton, Dickinson and Company · 2023
- Descendant · 2 generations on · 0 of its ownK252378 BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™…Becton, Dickinson and Company · 2026
Most influential descendants
Showing 2 of 2 · See all- K230391BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood…Becton, Dickinson and Company · 2023 · cites it directly1descendant
- K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood…Becton, Dickinson and Company · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K771370 | Icrotaineo Brand Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977 | 1 |
| 0 (this device) | K991702 | Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965… | Becton Dickinson Vacutainer Systems | 1999 | — |
| +1 | K230391 | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™… | Becton, Dickinson and Company | 2023 | — |
| +2 | K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™… | Becton, Dickinson and Company | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K771370 | Icrotaineo Brand TubeSummary page 3…e predicate devices, K number, and clearance dates are also identified in the table. Manufacturer Predicate Device K-Number Clearance Date Becton Dickinson MICROTAINER® K771370 8/3/77 VACUTAINER Brand Tubes Systems Becton Dickinson MICROTAINER® K931368/A 9/28/93 VACUTAINER Brand EDTA Tube Systems with MIC… | 1977 |
| * | K931368 | Microtainer Brand Tube with EdtaSummary page 3…e table. Manufacturer Predicate Device K-Number Clearance Date Becton Dickinson MICROTAINER® K771370 8/3/77 VACUTAINER Brand Tubes Systems Becton Dickinson MICROTAINER® K931368/A 9/28/93 VACUTAINER Brand EDTA Tube Systems with MICROGARD™ Closure _ Haonewca, M /£, 1999 Andrea Hroncich Date Regulatory Affa… | 1993 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230391 | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood… | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2019 | Class II | Z-0055-2020 | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. |
| May 13, 2019 | Class II | Z-0058-2020 | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. |
| May 13, 2019 | Class II | Z-0059-2020 | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. |
| May 13, 2019 | Class II | Z-0054-2020 | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. |
| May 13, 2019 | Class II | Z-0056-2020 | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. |
| May 13, 2019 | Class II | Z-0057-2020 | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. |
| May 13, 2019 | Class II | Z-0060-2020 | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. |
| May 13, 2019 | Class II | Z-0061-2020 | Process control | Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. |
| 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… |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K230391 (Becton, Dickinson and Company, 2023) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The MICROTAINER® Brand Chemistry tubes with MICROGARD™ Closure are intended to collect, transport, and store skin puncture blood specimens for chemistry determinations requiring serum or heparinized plasma.
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/K991702 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991702: Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963, 365967, 36578.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991702
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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