FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD Vacutainer® K2 EDTA Blood Collection Tubes
K Number: K231373
·
Decision Feb 2, 2024
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
134
Review Days
266
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Basic Information
- Device Name
- BD Vacutainer® K2 EDTA Blood Collection Tubes
- K Number
- K231373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson and Company
- Date Received
- May 12, 2023
- Decision Date
- February 2, 2024
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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Other Clearances by Becton, Dickinson and Company
| K Number | Device Name | ||
|---|---|---|---|
| K260128 | BD Preset and BD A-Line Arterial Blood Collection Syringes | Apr 15, 2026 | Substantially Equivalent |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | Apr 10, 2026 | Substantially Equivalent |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | Apr 10, 2026 | Substantially Equivalent |
| K260184 | Onclarity Self-Collection Kit | Apr 2, 2026 | Substantially Equivalent |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Mar 13, 2026 | Substantially Equivalent |
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe | Dec 2, 2025 | Substantially Equivalent |
| 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 | Oct 31, 2025 | Substantially Equivalent |
| K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O) | Sep 12, 2025 | Substantially Equivalent |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Aug 8, 2025 | Substantially Equivalent |
| K251350 | BD Plastipak Syringe | Jul 29, 2025 | Substantially Equivalent |