510(k) · Cleared
Recalled · Class II · 2026Bardex I.C. Latex Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · MJC Catheter, Urological (Antimicrobial) And Accessories
Cleared on Sep 29, 2004 after a 201-day review. The FDA summary names its predicate without a number. 17 later devices descend from it. It has been recalled 9 times.
- Decided
- Sep 29, 2004
- Review
- 201 days
- Class
- Class II
- Product code
- MJC
- Recalls
- 9
- Predicates
- 0
17 later devices descend from it, 3 citing it directly.
- This deviceK040658 Bardex I.C. Latex Foley CatheterC.R. Bard, Inc. · 2004
- Descendant · cites it directly · 10 of its ownK082815 Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments · 2008
- Descendant · cites it directly · 4 of its ownK091699 Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009
- Descendant · 2 generations on · 2 of its ownK162989 Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK233094 Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK212077 Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K082815Well Lead Silicone and Latex Foley CathetersWell Lead Medical Instruments · 2008 · cites it directly10descendants
- K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009 · cites it directly4descendants
- K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017 · 2 generations on2descendants
- K233094Wellead® Latex Foley CatheterWell Lead Medical (Hainan) Co., Ltd. · 2024 · 2 generations on1descendant
- K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040658 | Bardex I.C. Latex Foley Catheter | C.R. Bard, Inc. | 2004 | — |
| +1 | K082815 | Well Lead Silicone and Latex Foley Catheters | Well Lead Medical Instruments | 2008 | — |
| +1 | K091699 | Amsure Hydrophilic Latex Foley Catheter | Amsino International, Inc. | 2009 | — |
| +2 | K162989 | Rusch Simplastic Foley Catheters | Teleflexmedical, Inc. | 2017 | — |
| +2 | K233094 | Wellead® Latex Foley Catheter | Well Lead Medical (Hainan) Co., Ltd. | 2024 | — |
| +3 | K212077 | Teleflex Rusch SoftSimplastic Foley Catheters | Teleflexmedical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Bardex® I.C. Latex Foley Catheter Named without a submission number |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
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. |
| Jul 17, 2025 | Class II | Z-2590-2025 | Labeling mix-ups | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex… |
| Jul 17, 2025 | Class II | Z-2591-2025 | Labeling mix-ups | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex… |
| Jul 17, 2025 | Class II | Z-2589-2025 | Labeling mix-ups | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex… |
| May 9, 2024 | Class II | Z-2154-2024 | Component design/selection | Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices. |
| Aug 5, 2021 | Class II | Z-2525-2021 | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. |
| Aug 5, 2021 | Class II | Z-2527-2021 | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. |
| Aug 5, 2021 | Class II | Z-2523-2021 | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. |
| Apr 15, 2020 | Class II | Z-1970-2020 | Under Investigation by firm | There is potential for a white paper-type residue attached to the catheter. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082815 (Well Lead Medical Instruments, 2008) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MJC devicesMJC Catheter, Urological (Antimicrobial) And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MJC
1in 2024
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MJC
3,747in 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 | — |
What is it indicated for?
The Bardex® I.C. latex Foley catheter is indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040658: Bardex I.C. Latex 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/K040658
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026