510(k) · Cleared
ClearedBD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H 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 · GIM Tubes, Vacuum Sample, With Anticoagulant
Cleared on Nov 27, 2023 as substantially equivalent to K093972 (Becton, Dickinson & CO, 2010) after a 277-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Nov 27, 2023
- Review
- 277 days
- Class
- Class II
- Product code
- GIM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940905 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK940905 Microtainer Brand Tube with Edta (K2)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1994 · Recalled
- 1 generation backK093972 BD Microtainer Map Microtube for Automated Process, Model 363706Becton, Dickinson & CO · 2010 · Recalled
- This deviceK230493 BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H…Becton, Dickinson and Company · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940905 | Microtainer Brand Tube with Edta (K2) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | 2 |
| −1 | K093972 | BD Microtainer Map Microtube for Automated Process, Model 363706 | Becton, Dickinson & CO | 2010 | 1 |
| 0 (this device) | K230493 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary… | Becton, Dickinson and Company | 2023 | — |
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 GIM? 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 GIM device
- #1 K240455 BD Vacutainer® Citrate Blood Collection Tubesscore 8.3 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K093972 | BD Microtainer Map Microtube for Automated Process, Model 363706Summary page 5…Classification Regulation: 21 CFR §862.1675 Regulatory Class: Class II Panel: Clinical Chemistry Product Code: GIM Predicate Device Predicate: K093972 BD Microtainer® Microtube for Automated Process (MAP) Device Establishment Becton, Dickinson and Company Registration Number:… | 2010 |
| † | K223243 | BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets | 2022 |
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 29 years and passes through 3 companies; a new generation was cleared every 15.5 years on median.
- 2 of the 2 ancestors have a recall of any class.
- 1 other device also cites its predicate K093972.
How does its category compare?
All GIM devicesGIM Tubes, Vacuum Sample, With Anticoagulant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GIM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GIM
Too few GIM 510(k)s in any year since 2007 to give a median.
Recalls per year · GIM
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIM
641in 2025
MAUDE reports naming product code GIM, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 276 |
| 2019 | 0 | — | 0 | 145 |
| 2020 | 0 | — | 0 | 147 |
| 2021 | 0 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 2 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 316 |
| 2025 | 0 | — | 1 | 641 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ Hemoglobin & Hematocrit (H&H) Capillary Blood Collection Tube with K2EDTA is used to collect, anticoagulate, transport, and store capillary whole blood samples from individuals 18 years and older. The System is comprised of a capillary blood collection tube and a BD MiniDraw™ Finger Sleeve that are intended for use by a trained healthcare worker. BD MiniDraw™ Capillary Blood Collection…
Read the full statement (124 words)
The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ Hemoglobin & Hematocrit (H&H) Capillary Blood Collection Tube with K2EDTA is used to collect, anticoagulate, transport, and store capillary whole blood samples from individuals 18 years and older. The System is comprised of a capillary blood collection tube and a BD MiniDraw™ Finger Sleeve that are intended for use by a trained healthcare worker.
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube is intended for sample collection used in the measurement of Hemoglobin (HgB) & Hematocrit (HCT), when analyzed on Sysmex XN - Series™ systems.
The BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ H&H Capillary Blood Collection Tube is not intended for use with other parameters.
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/K230493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230493: BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230493
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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