Product code IZL: 510(k) clearances and predicates
Product code IZL covers XLITE. 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 IZL. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 16 |
| 2023 | 3 |
| 2024 | 9 |
| 2025 | 11 |
| 2026 so far | 5 |
Recent clearances
Newest IZL clearances in the FDA index, with applicant and decision date:
- K260236, XLITE, applicant GEMSS HEALTHCARE CO., LTD., decided 2026-08-03. FDA record
- K253058, Portable DR Imaging System, applicant Shantou Institute of Ultrasonic Instruments Co., Ltd., decided 2026-06-18. FDA record
- K260085, RAYMO Mobile X-ray System (Model: RAYMO), applicant DRGEM Corporation, decided 2026-05-14. FDA record
- K253185, Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System, applicant Carestream Health, decided 2026-03-11. FDA record
- K253244, AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini), applicant Poskom Co., Ltd., decided 2026-02-23. FDA record
- K250976, Airbile-100, applicant Poskom Co., Ltd., decided 2025-12-19. FDA record
- K251710, Mobile X-ray unit (!M1), applicant Solutions For Tomorrow AB, decided 2025-10-24. FDA record
- K243864, BONX805, applicant Bontech Co., Ltd., decided 2025-09-12. 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 Portable DR Imaging System, RAYMO Mobile X-ray System (Model: RAYMO). Watch new IZL 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 IZL?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent IZL clearances include XLITE.
How many 510(k) clearances use product code IZL?
237 at the time this page was generated, from openFDA records.
How do I find a predicate device under IZL?
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 IZL 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.