510(k) · Cleared
ClearedBD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary 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 Dec 1, 2023 as substantially equivalent to K991702 (Becton Dickinson Vacutainer Systems, 1999) after a 290-day review. Its family tree reaches back 2 generations to 1977. 1 later device descends from it.
- Decided
- Dec 1, 2023
- Review
- 290 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K771370 (1977). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK771370 Icrotaineo Brand TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1977 · Recalled
- 1 generation backK991702 Microtainer Brand Chemistry Tubes with Microgard Closure, Model…Becton Dickinson Vacutainer Systems · 1999 · Recalled
- This deviceK230391 BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™…Becton, Dickinson and Company · 2023
- Descendant · cites it directly · 0 of its ownK252378 BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™…Becton, Dickinson and Company · 2026
Most influential descendants
Showing 1 of 1 · See all- K252378BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood…Becton, Dickinson and Company · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771370 | Icrotaineo Brand Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977 | 1 |
| −1 | K991702 | Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965… | Becton Dickinson Vacutainer Systems | 1999 | 9 |
| 0 (this device) | K230391 | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™… | Becton, Dickinson and Company | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K991702 | Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963…Summary page 5…Classification Regulation: 21 CFR §862.1675 Regulatory Class: Class II Panel: Clinical Chemistry Product Code(s): JKA Predicate Device Predicate: K991702 BD Microtainer® SST™ Device Establishment Becton, Dickinson and Company Registration Number: 2243072 Performance Standards AS… | 1999 |
| † | K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood… | 2026 | 0 |
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?
- The line of descent spans 46 years and passes through 3 companies; a new generation was cleared every 24.3 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K252378 (Becton, Dickinson and Company, 2026) has gone furthest, with 0 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. 2023, 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 MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is used to collect, separate, transport, and store capillary blood samples from individuals 18 years and older. The system is comprised of a capillary blood collection tube and the BD MiniDraw™ Finger Sleeve that is intended for use by a trained healthcare worker. BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood…
Read the full statement (136 words)
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is
used to collect, separate, transport, and store capillary blood samples from individuals 18 years and older. The system is
comprised of a capillary blood collection tube and the BD MiniDraw™ Finger Sleeve that is intended for use by a trained
healthcare worker.
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube is
intended for sample collection used in the measurement of Alkaline Phosphatase (ALKP), Alanine Aminotransferase
(ALT), Sodium (Na), Chloride (Cl), Albumin (ALB), Blood Urea Nitrogen (BUN), Calcium (Ca), Creatinine (CREAT),
Total Bilirubin (TBIL), Total Protein (TP), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Total
Cholesterol (CHOL), and Triglycerides (TRIG).
BD MiniDraw™ SST™ Capillary Blood Collection Tube is not intended for use with other parameters/analytes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230391: BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230391
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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