Product code KOD: 510(k) clearances and predicates
Product code KOD covers Rubber Utility Catheter. FDA lists 238 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
238 clearances on file under product code KOD. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 2 |
| 2023 | 0 |
| 2024 | 0 |
| 2025 | 0 |
| 2026 so far | 1 |
Recent clearances
Newest KOD clearances in the FDA index, with applicant and decision date:
- K251864, Rubber Utility Catheter, applicant C.R. Bard, Inc., decided 2026-02-23. FDA record
- K220036, Wellead Ureteral Catheter, applicant Well Lead Medical Co., Ltd., decided 2022-12-16. FDA record
- K220730, allFlex Ureteral Catheters, Krait Ureteral Catheters, applicant Allwin Medical Devices, Inc., decided 2022-10-13. FDA record
- K211032, Urinary Catheter 12 Fr, Urinary Catheter 16 Fr, applicant Urogen Pharma, Ltd., decided 2021-11-19. FDA record
- K181979, Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter, applicant Teleflexmedical, Inc., decided 2019-05-24. FDA record
- K180354, UroGen Ureteral Catheter, applicant Urogen Pharma, Ltd., decided 2018-10-30. FDA record
- K181144, Angled Tip Ureteral Catheter, applicant Cook Incorporated, decided 2018-06-28. FDA record
- K180530, Imager II Urology Torque Catheter, applicant Boston Scientific Corporation, decided 2018-04-10. 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 Wellead Ureteral Catheter, allFlex Ureteral Catheters, Krait Ureteral Catheters. Watch new KOD 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 KOD?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent KOD clearances include Rubber Utility Catheter.
How many 510(k) clearances use product code KOD?
238 at the time this page was generated, from openFDA records.
How do I find a predicate device under KOD?
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 KOD clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.