510(k) · Cleared

Recalled · Class II · 2026

Bard (R) Hydrogel/Silver-Coated Foley Catheter

K910318510(k) TraditionalCleared Aug 18, 19941,302-day reviewClass II21 CFR 876.5130Recalls 8

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

C.R. Bard, Inc. · MJC Catheter, Urological (Antimicrobial) And Accessories

Cleared on Aug 18, 1994 after a 1,302-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 8 times.

Decided: Aug 18, 1994
Review: 1,302 days
Class: Class II
Product code: MJC
Recalls: 8
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK910318 Bard (R) Hydrogel/Silver-Coated Foley CatheterC.R. Bard, Inc. · 1994
Descendant · cites it directly · 0 of its ownK983101 Bardex I.C 4-Way Foley Catheter Model 1865SIXX XX = 18,20,22,24C.R. Bard, Inc. · 1998
Descendant · cites it directly · 0 of its ownK971627 Silicone Antibacterial Foley CatheterRochester Medical Corp. · 1998

Most influential descendants

Showing 2 of 2 · See all

K983101Bardex I.C 4-Way Foley Catheter Model 1865SIXX XX = 18,20,22,24C.R. Bard, Inc. · 1998 · cites it directly0descendants
K971627Silicone Antibacterial Foley CatheterRochester Medical Corp. · 1998 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K910318	Bard (R) Hydrogel/Silver-Coated Foley Catheter	C.R. Bard, Inc.	1994	—
+1	K983101	Bardex I.C 4-Way Foley Catheter Model 1865SIXX XX = 18,20,22,24	C.R. Bard, Inc.	1998	—
+1	K971627	Silicone Antibacterial Foley Catheter	Rochester Medical Corp.	1998	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0

FIG. 1 — Lineage of K910318, 1994–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MJC? 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 MJC device

#1 K233094 Wellead® Latex Foley Catheterscore 11.1 · 3 generations · no Class I recall

Get a 510(k) Report

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? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K983101	Bardex I.C 4-Way Foley Catheter Model 1865SIXX XX = 18,20,22,24	C.R. Bard, Inc.	1998	0
K971627	Silicone Antibacterial Foley Catheter	Rochester Medical Corp.	1998	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 25, 2026	Class II	Z-3116-2026	Under Investigation by firm	Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Aug 5, 2021	Class II	Z-2524-2021	Packaging change control	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Class II	Z-2526-2021	Packaging change control	There is potential for packaging defects that may impact the sterile barrier.
Aug 5, 2021	Class II	Z-2522-2021	Packaging change control	There is potential for packaging defects that may impact the sterile barrier.
Dec 13, 2018	Class II	Z-0803-2019	Device Design	potential for urine leakage around the vent on the vented sample port
Dec 6, 2018	Class II	Z-0800-2019	Device Design	Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
Dec 18, 2015	Class II	Z-1359-2016	Error in labeling	Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
Dec 18, 2015	Class II	Z-1358-2016	Error in labeling	Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K983101 (C.R. Bard, Inc., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MJC devices

MJC Catheter, Urological (Antimicrobial) And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJC

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MJC

Too few MJC 510(k)s in any year since 2007 to give a median.

Recalls per year · MJC

2in 2018

2007high 2 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MJC

3,747in 2025

2007high 3,747 (2025) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	2
2010	0	—	0	1
2011	0	—	0	0
2012	0	—	0	5
2013	0	—	0	8
2014	0	—	0	13
2015	0	—	1	25
2016	0	—	1	134
2017	0	—	0	714
2018	0	—	2	613
2019	0	—	0	1,270
2020	0	—	0	1,433
2021	0	—	0	1,464
2022	0	—	0	1,796
2023	0	—	0	1,987
2024	1	—	0	1,960
2025	0	—	0	3,747
2026	0	—	1	—

https://510kreport.com/device/K910318 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910318: Bard (R) Hydrogel/Silver-Coated Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910318

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026