Product code IYE: 510(k) clearances and predicates
Product code IYE covers AerFrame Alignment Laser Box (LBV2). FDA lists 738 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
738 clearances on file under product code IYE. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 12 |
| 2023 | 18 |
| 2024 | 9 |
| 2025 | 12 |
| 2026 so far | 14 |
Recent clearances
Newest IYE clearances in the FDA index, with applicant and decision date:
- K261865, AerFrame Alignment Laser Box (LBV2), applicant Stabilix, LLC, decided 2026-09-16. FDA record
- K261718, EZFluence (RADEZ V2), applicant Radformation, Inc., decided 2026-08-31. FDA record
- K260733, MRIA Radiation Therapy Information System (MRIA), applicant Manteia Technologies Co., Ltd., decided 2026-08-26. FDA record
- K261856, Halcyon, Ethos Radiotherapy System (5.0), applicant Varian Medical Systems, Inc., decided 2026-08-03. FDA record
- K252937, ThinkQA 3, applicant Dosisoft SA, decided 2026-06-12. FDA record
- K253004, LUNA 3D, applicant Lap GmbH Laser Applikationen, decided 2026-06-04. FDA record
- K260792, AerFrame Patient Immobilization System (AFPIS), applicant Stabilix, LLC, decided 2026-05-08. FDA record
- K252258, VERIQA RT EPID 3D, applicant Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla, decided 2026-04-15. 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 EZFluence (RADEZ V2), MRIA Radiation Therapy Information System (MRIA). Watch new IYE 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 IYE?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent IYE clearances include AerFrame Alignment Laser Box (LBV2).
How many 510(k) clearances use product code IYE?
738 at the time this page was generated, from openFDA records.
How do I find a predicate device under IYE?
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 IYE 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.