FDA product code KOD: Catheter, Urological
KOD is the FDA product code for catheter, urological. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 238 510(k) submissions under KOD, 3 in the last five years, from 120 different applicants. The average 510(k) review took 90 days (median 64); 251 days on average over the last three years. FDA has posted 108 recalls for KOD devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Urological |
| Device class | Class II |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KOD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 57 |
| 2018 | 6 | 188 |
| 2019 | 1 | 303 |
| 2021 | 1 | 226 |
| 2022 | 2 | 279 |
| 2026 | 1 | 251 |
Compare with all 510(k) review times · Search every KOD clearance
Top KOD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 10 | 2026-02-23 |
| Abco Dealers, Inc. | 9 | 1984-07-19 |
| Van-Tec, Inc. | 8 | 1988-02-11 |
| The Kendal Co. | 7 | 1989-07-14 |
| Cook Urological, Inc. | 6 | 1993-12-22 |
115 more applicants have KOD clearances. See the full list in Caduvo.
Most recent KOD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251864 | C.R. Bard, Inc. | Rubber Utility Catheter | 2026-02-23 | 251 |
| K220036 | Well Lead Medical Co., Ltd. | Wellead Ureteral Catheter | 2022-12-16 | 345 |
| K220730 | Allwin Medical Devices, Inc. | allFlex Ureteral Catheters, Krait Ureteral Catheters | 2022-10-13 | 213 |
| K211032 | Urogen Pharma, Ltd. | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | 2021-11-19 | 226 |
| K181979 | Teleflexmedical, Inc. | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | 2019-05-24 | 303 |
Recalls for KOD devices
108 product recalls in 25 recall events; 7 initiated in the last five years and 6 still open. Most recent: 2026-06-25.
| Year | Recalls |
|---|---|
| 2018 | 6 |
| 2019 | 2 |
| 2020 | 11 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code KOD?
KOD is the FDA product code for catheter, urological. It is a Class II device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is KOD?
Class II, regulation 21 CFR 876.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code KOD?
Across 238 cleared submissions the average was 90 days from receipt to decision (median 64).
Which companies have the most KOD clearances?
C.R. Bard, Inc. (10); Abco Dealers, Inc. (9); Van-Tec, Inc. (8); The Kendal Co. (7); Cook Urological, Inc. (6).
Have KOD devices been recalled?
Yes: 108 product recalls across 25 recall events; the most recent began 2026-06-25.
Next steps
- Run an FDA pathway report with predicate devices for product code KOD
- Run a recall and safety report across every KOD manufacturer
- Watch product code KOD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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