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 Apr 10, 2026 as substantially equivalent to K230391 (Becton, Dickinson and Company, 2023) after a 254-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Apr 10, 2026
- Review
- 254 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K771370 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK771370 Icrotaineo Brand TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1977 · Recalled
- 2 generations backK991702 Microtainer Brand Chemistry Tubes with Microgard Closure, Model…Becton Dickinson Vacutainer Systems · 1999 · Recalled
- 1 generation backK230391 BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™…Becton, Dickinson and Company · 2023
- This deviceK252378 BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™…Becton, Dickinson and Company · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771370 | Icrotaineo Brand Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977 | 1 |
| −2 | K991702 | Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965… | Becton Dickinson Vacutainer Systems | 1999 | 9 |
| −1 | K230391 | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™… | Becton, Dickinson and Company | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K230391 | BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood…Summary page 6…Classification Regulation: 21 CFR 862.1675 Regulatory Class: Class II Panel: Clinical Chemistry Product Code: JKA 1.10 Predicate Device BD® MiniDraw™ SST™ System (K230391) 1.11 Device Establishment Becton, Dickinson and Company 1.12 Registration Number 2243072 1.13 Performance Stand… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 49 years and passes through 3 companies; a new generation was cleared every 22.0 years on median.
- 3 of the 4 ancestors have a recall of any class.
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. 2026, 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 (143 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 Albumin (ALB), Alkaline Phosphatase (ALKP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Blood Urea Nitrogen (BUN), Calcium (Ca), Chloride (Cl), Creatinine (CREAT), Glucose (GLU), Potassium (K), Sodium (Na), 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/K252378 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252378: 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 5, 2026. https://510kreport.com/device/K252378
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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