BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube— 510(k) K252378
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K252378 for BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube, Substantially Equivalent on 2026-04-10. Applicant: Becton, Dickinson and Company. Device class: 2.
Summary
BD MiniDraw is a capillary blood collection system, cleared here with a MiniDraw SST tube. SST means serum separator tube, so the sample is meant for serum chemistry testing. Capillary collection takes blood from a fingerstick instead of a vein. Product code JKA covers blood collection tubes, vials, and serum separator systems.
Class II, 21 CFR 862.1675. The Clinical Chemistry panel reviewed it as a Traditional 510(k).
Becton, Dickinson and Company filed from Franklin Lakes, New Jersey. BD is the biggest name in blood collection and files under JKA regularly. Review took 254 days (July 30, 2025 to April 10, 2026).
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Code JKA
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
Recent devices under product code JKA
view all- K252899 — Female Culture Device; Male Culture Device; Transfer Device; Access Device
- K260128 — BD Preset and BD A-Line Arterial Blood Collection Syringes
- K252506 — BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder
- K252040 — BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
- K251812 — Steripath® Flow Blood Collection System
More clearances from Becton, Dickinson and Company
view all- K260184 — Onclarity Self-Collection Kit
- K250884 — 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
- K250358 — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System
- K250059 — BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)
- K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
Adverse events under product code JKA
product code JKA- Injury
- 455
- Malfunction
- 26,686
- Other
- 4
- Total
- 27,145
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.