510(k) Report

510(k) · Cleared

Recalled · 2011

Sterile Catherization Procedure Trays

K830359510(k) TraditionalCleared Mar 17, 198342-day reviewClass II21 CFR 876.5130Recalls 16

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Welcon, Inc. · KOD Catheter, Urological

Cleared on Mar 17, 1983 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 16 times.

Decided
Mar 17, 1983
Review
42 days
Class
Class II
Product code
KOD
Recalls
16
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K830359Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KOD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KOD device

  1. #1 K251864 Rubber Utility Catheterscore 10.9 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 2, 2011Not classifiedZ-0493-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0494-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0495-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0492-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0496-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0503-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0504-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0490-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0491-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0497-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0499-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0500-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0501-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0502-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0505-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.
Sep 2, 2011Not classifiedZ-0498-2012Component design/selectionNurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.

The 5 latest of 16 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KOD devices

KOD Catheter, Urological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KOD

2in 2022

2008: 22009: 12010: 12011: 22014: 12016: 22017: 12018: 62019: 12021: 12022: 22026 (partial year): 1
2007high 6 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KOD

251in 2018

2018: 251 days median
2007high 251 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KOD

1in 2023

2009: 152010: 12011: 472012: 22016: 12019: 12022: 32023: 1, 1 Class I2026 (partial year): 1
2007high 47 (2011) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KOD

1,389in 2025

2007: 1802008: 1022009: 1832010: 2282011: 2092012: 1652013: 3932014: 2262015: 4182016: 2842017: 1,8732018: 1,1792019: 1,1672020: 1,3702021: 1,3882022: 1,2802023: 1,1602024: 1,2592025: 1,389
2007high 1,873 (2017) · low 102 (2008)2025

MAUDE reports naming product code KOD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—0180
20082—0102
20091—15183
20101—1228
20112—47209
20120—2165
20130—0393
20141—0226
20150—0418
20162—1284
20171—01,873
2018625101,179
20191—11,167
20200—01,370
20211—01,388
20222—31,280
20230—1 (1)1,160
20240—01,259
20250—01,389
20261—1—

More from Welcon, Inc.

8 FDA decisions under this applicant name. See the company

  • K003402Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device IrrigationWelcon, Inc. · 2001
  • K973734Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationWelcon, Inc. · 1998
  • K971764Welcon Hue-VU Urinary Drainage BagWelcon, Inc. · 1997
  • K912869Women and Infant's Delivery PackWelcon, Inc. · 1991
  • K904158Accorde (R) Irrigating Syringe/Procedure TrayWelcon, Inc. · 1990

Recent decisions in KOD

The KOD category page

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  • K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd. · 2022
  • K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc. · 2022
  • K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd. · 2021
  • K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc. · 2019

https://510kreport.com/device/K830359 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830359: Sterile Catherization Procedure Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830359

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026