510(k) · Cleared
Recalled · Class II · 2026Bardex Lubri-Sil I.C. Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Medical Div. · MJC Catheter, Urological (Antimicrobial) And Accessories
Cleared on Feb 16, 1999 after a 90-day review. The FDA summary names its predicate without a number. It has been recalled 2 times.
- Decided
- Feb 16, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- MJC
- Recalls
- 2
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (2)
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® All-Silicone Foley Catheter Named without a submission number | |
| * | — | Bardex® I.C. Foley Catheter (LATEx) Named without a submission number |
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
| 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 29, 2002 | Not classified | Z-1144-03 | Other | On some units the inflation valve labeling is reversed on the Prostate and Bladder balloon inflation ports. |
No ancestor or descendant has a Class I recall.
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® Lubri-Sil™ I.C. 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 a nephrostomy tract.
Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis following surgery such as transurethral resection of the prostate.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984136 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984136: Bardex Lubri-Sil I.C. Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984136
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026