FDA product code · Gastroenterology, Urology
KODCatheter, Urological
Product code KOD covers Catheter, Urological, a Class II device regulated under 21 CFR 876.5130. FDA has cleared 238 devices in this code, 1 of them in the last 12 months. Median review time across the 238 most recent decisions is 64 days. openFDA lists 107 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 876.5130
- Review panel
- Gastroenterology, Urology
- Clearances
- 238
What is happening in KOD right now?
KOD (Catheter, Urological): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in KOD?
FDA has cleared 238 devices under product code KOD since the 510(k) programme began in 1976, 1 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251864 | Rubber Utility Catheter | C.R. Bard, Inc. | |
| K220036 | Wellead Ureteral Catheter | Well Lead Medical Co., Ltd. | |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral Catheters | Allwin Medical Devices, Inc. | |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 Fr | Urogen Pharma, Ltd. | |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter | Teleflexmedical, Inc. | |
| K180354 | UroGen Ureteral Catheter | Urogen Pharma, Ltd. | |
| K181144 | Angled Tip Ureteral Catheter | Cook Incorporated | |
| K180530 | Imager II Urology Torque Catheter | Boston Scientific Corporation | |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter | Cook Incorporated | |
| K171600 | Renal Access Cobra Catheter, Kumpe Access Catheter | Cook Incorporated |
How long does FDA review take for KOD?
The median FDA review time for KOD is 64 days, measured across the 238 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KOD?
openFDA lists 107 recall records against product code KOD. A recall record covers one firm's corrective action and may span many device lots.
Z-2074-2025Open, ClassifiedC.R. Bard, Inc.
Cather packaging may contain the incorrect French size.
Z-2075-2025Open, ClassifiedC.R. Bard, Inc.
Cather packaging may contain the incorrect French size.
Z-1052-2024Open, ClassifiedCardinal Health 200, LLC
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Z-0227-2023Open, ClassifiedTeleflex, Inc.
Product may not be sterile
Z-0666-2022TerminatedC.R. Bard, Inc.
There is a potential to leak from the catheter where it connects to the drain bag
Showing the 5 most recently initiated of 107. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KOD?
MAUDE holds 3,759 adverse-event reports naming product code KOD, 668 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KOD unusual?
One month sits above KOD's own expected range: 1 March 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 51 | Insufficient history | No expected range — too little history | |
| 115 | Insufficient history | No expected range — too little history | |
| 93 | Insufficient history | No expected range — too little history | |
| 111 | Insufficient history | No expected range — too little history | |
| 117 | Insufficient history | No expected range — too little history | |
| 91 | Insufficient history | No expected range — too little history | |
| 99 | Insufficient history | No expected range — too little history | |
| 69 | Insufficient history | No expected range — too little history | |
| 90 | Insufficient history | No expected range — too little history | |
| 148 | Insufficient history | No expected range — too little history | |
| 88 | Insufficient history | No expected range — too little history | |
| 81 | Insufficient history | No expected range — too little history | |
| 96 | Insufficient history | No expected range — too little history | |
| 101 | Insufficient history | No expected range — too little history | |
| 87 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 71 | Insufficient history | No expected range — too little history | |
| 100 | Insufficient history | No expected range — too little history | |
| 91 | Insufficient history | No expected range — too little history | |
| 109 | Insufficient history | No expected range — too little history | |
| 211 | Insufficient history | No expected range — too little history | |
| 95 | 49–188 | Within expected (49–188) | |
| 94 | 41–152 | Within expected (41–152) | |
| 246 | 45–169 | Above expected (45–169) | |
| 106 | 44–264 | Within expected (44–264) | |
| 82 | 28–234 | Within expected (28–234) | |
| 174 | 13–228 | Within expected (13–228) | |
| 138 | 37–392 | Within expected (37–392) | |
| 62 | 14–275 | Within expected (14–275) | |
| 101 | 0–266 | Within expected (0–266) | |
| 71 | 0–258 | Within expected (0–258) | |
| 92 | 0–224 | Within expected (0–224) | |
| 79 | 0–250 | Within expected (0–250) | |
| 126 | 0–269 | Within expected (0–269) | |
| 86 | 0–232 | Within expected (0–232) | |
| 69 | 0–255 | Within expected (0–255) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in KOD.
What are the predicate devices in KOD?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KOD?
Across the 238 most recent decisions, these applicants filed most often in KOD.
| Applicant | Recent clearances |
|---|---|
| C.R. Bard, Inc. | 10 |
| Abco Dealers, Inc. | 9 |
| Van-Tec, Inc. | 8 |
| The Kendal Co. | 7 |
| American Pharmaseal Div. Ahsc | 6 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch KOD
Get an email the morning anything changes in KOD — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Gastroenterology, Urology
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.