Product code DXC: 510(k) clearances and predicates
Product code DXC covers PreludeSYNC™ Radial Compression Device. FDA lists 205 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
205 clearances on file under product code DXC. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 4 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 so far | 4 |
Recent clearances
Newest DXC clearances in the FDA index, with applicant and decision date:
- K262086, PreludeSYNC™ Radial Compression Device, applicant Merit Medical Systems, Inc., decided 2026-07-22. FDA record
- K260105, Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts, applicant Edwards Lifesciences, decided 2026-06-05. FDA record
- K252772, Arc Adjustable Radial Cuff Compression Device, applicant Tz Medical, Inc., decided 2026-05-22. FDA record
- K254060, Life Saving Tourniquet, applicant TW Medical, decided 2026-04-03. FDA record
- K243627, Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC), applicant Arc Trauma, LLC, decided 2025-12-31. FDA record
- K253070, Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL), applicant Medline Industries, LP, decided 2025-11-20. FDA record
- K232577, Radial Compression Device, applicant Ningbo Dizegens Medical Science Co.,Ltd, decided 2024-01-18. FDA record
- K230281, PICOCLAMP, applicant Kono Seisakusho Co., Ltd., decided 2023-10-23. 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 Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts, Arc Adjustable Radial Cuff Compression Device. Watch new DXC 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 DXC?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DXC clearances include PreludeSYNC™ Radial Compression Device.
How many 510(k) clearances use product code DXC?
205 at the time this page was generated, from openFDA records.
How do I find a predicate device under DXC?
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 DXC clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.