Product code HRX: 510(k) clearances and predicates
Product code HRX covers Fule Vertebroplasty Balloon Catheter. FDA lists 683 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
683 clearances on file under product code HRX. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 4 |
| 2024 | 6 |
| 2025 | 9 |
| 2026 so far | 5 |
Recent clearances
Newest HRX clearances in the FDA index, with applicant and decision date:
- K260203, Fule Vertebroplasty Balloon Catheter, applicant Beijing Fule Science & Technology Development Co., Ltd., decided 2026-08-28. FDA record
- K254103, HOPKINS Telescopes for Arthroscopy, applicant Karl Storz SE & CO. KG, decided 2026-08-26. FDA record
- K252790, Digital ClarusScope System and Digital NeuroPEN System, applicant Clarus Medical, LLC, decided 2026-05-26. FDA record
- K253523, Freedom DS Decompression System, applicant Spinal Simplicity, decided 2026-04-16. FDA record
- K252546, VantageTM Lumbar Decompression Kit, applicant Allevion Medical, LLC, decided 2026-03-12. FDA record
- K253217, MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700), applicant Medimaging Integrated Solution, Inc (Miis), decided 2025-12-23. FDA record
- K250795, PUREVUE FMS, applicant W.O.M. World of Medicine GmbH, decided 2025-12-05. FDA record
- K252666, Articulator Arthroscopic Bur, applicant Joint Preservation Innovations, LLC, decided 2025-11-21. 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 HOPKINS Telescopes for Arthroscopy, Digital ClarusScope System and Digital NeuroPEN System. Watch new HRX 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 HRX?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HRX clearances include Fule Vertebroplasty Balloon Catheter.
How many 510(k) clearances use product code HRX?
683 at the time this page was generated, from openFDA records.
How do I find a predicate device under HRX?
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 HRX clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.