FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
K Number: K252040
·
Decision Mar 13, 2026
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
134
Review Days
256
Basic Information
- Device Name
- BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
- K Number
- K252040
- 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
- June 30, 2025
- Decision Date
- March 13, 2026
- 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 |
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| K Number | Device Name | ||
|---|---|---|---|
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| K251350 | BD Plastipak Syringe | Jul 29, 2025 | Substantially Equivalent |
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