Product code KPR: 510(k) clearances and predicates
Product code KPR covers EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H. FDA lists 359 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
359 clearances on file under product code KPR. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 8 |
| 2023 | 9 |
| 2024 | 11 |
| 2025 | 8 |
| 2026 so far | 6 |
Recent clearances
Newest KPR clearances in the FDA index, with applicant and decision date:
- K260227, EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H, applicant DRTECH Corporation, decided 2026-09-08. FDA record
- K260488, MULTIX Impact; MULTIX Impact C, applicant Siemens Medical Solutions USA, Inc., decided 2026-08-31. FDA record
- K260481, GC85A, applicant Samsung Electronics Co., Ltd., decided 2026-08-27. FDA record
- K260482, DRE Duo, applicant Jpi Healthcare Co, Ltd., decided 2026-06-15. FDA record
- K253446, AeroDR TX c02, applicant Dk Medical Systems Co., Ltd., decided 2026-04-10. FDA record
- K250954, DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector, applicant Carestream Health, decided 2026-01-20. FDA record
- K252000, uDR Arria & uDR Aris, applicant Shanghai United Imaging Healthcare Co., Ltd., decided 2025-11-26. FDA record
- K251167, uDR Aurora CX, applicant Shanghai United Imaging Healthcare Co., Ltd., decided 2025-09-19. 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 MULTIX Impact; MULTIX Impact C, GC85A. Watch new KPR 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 KPR?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KPR clearances include EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H.
How many 510(k) clearances use product code KPR?
359 at the time this page was generated, from openFDA records.
How do I find a predicate device under KPR?
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 KPR clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.