Product code IYO: 510(k) clearances and predicates
Product code IYO covers MD-6000S Bladder Scanner. FDA lists 895 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
895 clearances on file under product code IYO. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 5 |
| 2023 | 11 |
| 2024 | 10 |
| 2025 | 7 |
| 2026 so far | 8 |
Recent clearances
Newest IYO clearances in the FDA index, with applicant and decision date:
- K260313, MD-6000S Bladder Scanner, applicant MEDA Co., Ltd., decided 2026-09-24. FDA record
- K253452, Accuro 3S, applicant Rivanna Medical, Inc., decided 2026-07-24. FDA record
- K260190, ARTHUR, applicant ROPCA ApS, decided 2026-06-18. FDA record
- K252237, EdgeFlow UW20, applicant Edgecare, Inc., decided 2026-04-17. FDA record
- K254021, Accuro XV, applicant Rivanna Medical, Inc., decided 2026-04-09. FDA record
- K253898, QT Scanner 2000 Model A, applicant QT Imaging Holdings, Inc., decided 2026-03-04. FDA record
- K253714, IntraSight Plus, applicant Philips Image Guided Therapy Corporation, decided 2026-02-24. FDA record
- K253221, Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro), applicant Eieling Technology (Shenzhen) Limited, decided 2026-02-06. 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 Accuro 3S, ARTHUR. Watch new IYO 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 IYO?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent IYO clearances include MD-6000S Bladder Scanner.
How many 510(k) clearances use product code IYO?
895 at the time this page was generated, from openFDA records.
How do I find a predicate device under IYO?
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 IYO 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.