Product code KNS: 510(k) clearances and predicates
Product code KNS covers Rezum System. FDA lists 189 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
189 clearances on file under product code KNS. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 9 |
| 2024 | 3 |
| 2025 | 11 |
| 2026 so far | 2 |
Recent clearances
Newest KNS clearances in the FDA index, with applicant and decision date:
- K262460, Rezum System, applicant Boston Scientific, decided 2026-09-03. FDA record
- K260962, Sphincterotome, applicant Taewoong Medical Co., Ltd., decided 2026-05-21. FDA record
- K252388, Vanquish Water Vapor Ablation Device, applicant Francis Medical, Inc., decided 2025-11-26. FDA record
- K252889, Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M), applicant Olympus Medical Systems Corporation, decided 2025-11-25. FDA record
- K250945, Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series), applicant Olympus Medical Systems Corp., decided 2025-10-17. FDA record
- K250351, Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U), applicant Olympus Medical Systems Corporation, decided 2025-10-10. FDA record
- K251104, SureTome SW Sphincterotome with DomeTip, applicant Wilson-Cook Medical, decided 2025-09-29. FDA record
- K251226, Aqua Medical RF Vapor Ablation System, applicant Aqua Medical, Inc., decided 2025-08-08. 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 Sphincterotome, Vanquish Water Vapor Ablation Device. Watch new KNS 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 KNS?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KNS clearances include Rezum System.
How many 510(k) clearances use product code KNS?
189 at the time this page was generated, from openFDA records.
How do I find a predicate device under KNS?
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 KNS 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.