Product code IYN: 510(k) clearances and predicates
Product code IYN covers EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System. FDA lists 1185 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
1185 clearances on file under product code IYN. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 53 |
| 2023 | 44 |
| 2024 | 50 |
| 2025 | 57 |
| 2026 so far | 40 |
Recent clearances
Newest IYN clearances in the FDA index, with applicant and decision date:
- K262548, EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System, applicant Philips Ultrasound, LLC, decided 2026-09-25. FDA record
- K263182, EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System, applicant Samsung Medison Co., Ltd., decided 2026-09-25. FDA record
- K261313, Vivid Explorer/Vivid Advanced/Vivid Focus, applicant GE Medical Systems Ultrasound and Primary Care Diagnostics, decided 2026-09-02. FDA record
- K254027, Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90), applicant Sonoscape Medical Corp., decided 2026-08-24. FDA record
- K261668, Venue Go, applicant GE Medical Systems Ultrasound and Primary care Diagnostics, LLC, decided 2026-08-07. FDA record
- K262311, Alturion Series Diagnostic Ultrasound System, applicant Philips Ultrasound, LLC, decided 2026-08-04. FDA record
- K261288, Handheld Ultrasound Scanner, applicant IMGFAX CO., LTD., decided 2026-07-30. FDA record
- K261835, LOGIQ Focus, applicant GE Medical Systems Ultrasound and Primary Care Diagnostics, decided 2026-07-30. 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 EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System, Vivid Explorer/Vivid Advanced/Vivid Focus. Watch new IYN 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 IYN?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent IYN clearances include EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System.
How many 510(k) clearances use product code IYN?
1185 at the time this page was generated, from openFDA records.
How do I find a predicate device under IYN?
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 IYN 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.