Rubber Utility Catheter— 510(k) K251864
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K251864 for Rubber Utility Catheter, Substantially Equivalent on 2026-02-23. Applicant: C.R. Bard, Inc.. Device class: 2.
Summary
C.R. Bard's Rubber Utility Catheter is filed under product code KOD, urological catheter. The record doesn't describe the catheter beyond its name and that code name.
Class II, 21 CFR 876.5130. Gastroenterology, Urology is both the classification panel and the review panel. It came in as a Traditional 510(k).
C.R. Bard filed from Covington, Georgia. Review took 251 calendar days (June 17, 2025 to February 23, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Product code KOD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Covington, GA, US
Recent devices under product code KOD
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view all- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more
- K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
- K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P) +4 more
Adverse events under product code KOD
product code KOD- Death
- 5
- Injury
- 1,129
- Malfunction
- 7,019
- Total
- 8,153
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.