Product code DYB: 510(k) clearances and predicates
Product code DYB covers NAMIC Dilator and Sheath. FDA lists 706 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
706 clearances on file under product code DYB. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 13 |
| 2023 | 15 |
| 2024 | 18 |
| 2025 | 16 |
| 2026 so far | 16 |
Recent clearances
Newest DYB clearances in the FDA index, with applicant and decision date:
- K253526, NAMIC Dilator and Sheath, applicant Medline Industries, LP, decided 2026-07-29. FDA record
- K261529, Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04), applicant Hartman Medical Group, LLC, decided 2026-07-06. FDA record
- K261242, SimplGuide, applicant Pendracare, decided 2026-06-25. FDA record
- K261950, Health Line Tearaway Introducer, applicant Health Line International Corporation, decided 2026-06-22. FDA record
- K261492, FieldFlex Steerable Sheath, applicant CenterPoint Systems, LLC, decided 2026-06-05. FDA record
- K260606, Echo Large Bore Introducer Sheath, applicant Echo Medical, LLC, decided 2026-04-29. FDA record
- K254248, Introducer Sheath Set, applicant Cardiocycle Medical(Suzhou) Co., Ltd., decided 2026-04-23. FDA record
- K254279, Edwards eSheath+ introducer set, applicant Edwards Lifesciences, decided 2026-04-17. 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 Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04), SimplGuide. Watch new DYB 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 DYB?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DYB clearances include NAMIC Dilator and Sheath.
How many 510(k) clearances use product code DYB?
706 at the time this page was generated, from openFDA records.
How do I find a predicate device under DYB?
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 DYB clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.