Product code JKA: 510(k) clearances and predicates
Product code JKA covers Profoject Safety Sliding Blood Collection Set. FDA lists 237 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
237 clearances on file under product code JKA. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 9 |
| 2023 | 16 |
| 2024 | 6 |
| 2025 | 7 |
| 2026 so far | 6 |
Recent clearances
Newest JKA clearances in the FDA index, with applicant and decision date:
- K262215, Profoject Safety Sliding Blood Collection Set, applicant CMT Health PTE., Ltd., decided 2026-09-25. FDA record
- K252899, Female Culture Device; Male Culture Device; Transfer Device; Access Device, applicant Zhejiang Kindly Medical Device Co., Ltd., decided 2026-06-02. FDA record
- K260128, BD Preset and BD A-Line Arterial Blood Collection Syringes, applicant Becton, Dickinson and Company, decided 2026-04-15. FDA record
- K252378, BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube, applicant Becton, Dickinson and Company, decided 2026-04-10. FDA record
- K252506, BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder, applicant Becton, Dickinson and Company, decided 2026-04-10. FDA record
- K252040, BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes, applicant Becton, Dickinson and Company, decided 2026-03-13. FDA record
- K251812, Steripath® Flow Blood Collection System, applicant Magnolia Medical Technologies, decided 2025-09-25. FDA record
- K243207, BD Vacutainer® Eclipse Blood Collection Needle, applicant Becton, Dickinson and Company, decided 2025-07-03. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Female Culture Device; Male Culture Device; Transfer Device; Access Device, BD Preset and BD A-Line Arterial Blood Collection Syringes. Watch new JKA clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JKA?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JKA clearances include Profoject Safety Sliding Blood Collection Set.
How many 510(k) clearances use product code JKA?
237 at the time this page was generated, from openFDA records.
How do I find a predicate device under JKA?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JKA clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.