Product code DQX: 510(k) clearances and predicates
Product code DQX covers Hyperdrive 35 Guidewire. FDA lists 768 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
768 clearances on file under product code DQX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 15 |
| 2023 | 10 |
| 2024 | 11 |
| 2025 | 10 |
| 2026 so far | 11 |
Recent clearances
Newest DQX clearances in the FDA index, with applicant and decision date:
- K253146, Hyperdrive 35 Guidewire, applicant Rapid-Medical , Ltd., decided 2026-09-18. FDA record
- K261281, CROSSLEAD Standard 035 and CROSSLEAD Stiff 035, applicant Filmecc Co., Ltd., decided 2026-09-03. FDA record
- K253667, Accoat Guide Wire, applicant Sp Medical A/S, decided 2026-07-14. FDA record
- K261640, Merit MAK Nitinol/Gold-Tungsten Guide Wire, applicant Merit Medical Ireland , Ltd., decided 2026-07-13. FDA record
- K254137, InQwire Amplatz Guide Wire, applicant Merit Medical Ireland, Ltd., decided 2026-05-22. FDA record
- K260544, FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40, applicant FMD Co., Ltd., decided 2026-03-20. FDA record
- K253746, Enroute 0.014'' Transcarotid Guidewire, applicant Lake Region Medical, decided 2026-03-19. FDA record
- K253262, EmeryGlide (EG18008901), applicant Nano4imaging GmbH, decided 2026-03-06. 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 CROSSLEAD Standard 035 and CROSSLEAD Stiff 035, Accoat Guide Wire. Watch new DQX 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 DQX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DQX clearances include Hyperdrive 35 Guidewire.
How many 510(k) clearances use product code DQX?
768 at the time this page was generated, from openFDA records.
How do I find a predicate device under DQX?
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 DQX clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.