FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Onclarity Self-Collection Kit
K Number: K260184
·
Decision Apr 2, 2026
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
1
Applicant Total
134
Review Days
71
Basic Information
- Device Name
- Onclarity Self-Collection Kit
- K Number
- K260184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.2920
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Becton, Dickinson and Company
- Date Received
- January 21, 2026
- Decision Date
- April 2, 2026
- Product Code
- SEP
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| SEP | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (SEP), ordered by most recent decision date.
View allOther 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 |
| 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 |
| K243207 | BD Vacutainer® Eclipse Blood Collection Needle | Jul 3, 2025 | Substantially Equivalent |