510(k) · Cleared
ClearedBardex I.C 4-Way Foley Catheter Model 1865SIXX XX = 18,20,22,24
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 Nov 3, 1998 as substantially equivalent to K922431 (C.R. Bard, Inc., 1993) and 1 other predicate after a 61-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 3, 1998
- Review
- 61 days
- Class
- Class II
- Product code
- MJC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922431 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK922431 Bard Latex Urinary CathetersC.R. Bard, Inc. · 1993
- This deviceK983101 Bardex I.C 4-Way Foley Catheter Model 1865SIXX XX = 18,20,22,24C.R. Bard, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922431 | Bard Latex Urinary Catheters | C.R. Bard, Inc. | 1993 | — |
| 0 (this device) | K983101 | Bardex I.C 4-Way Foley Catheter Model 1865SIXX XX = 18,20,22,24 | C.R. Bard, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (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 |
|---|---|---|---|
| * | K922431 | Bard Latex Urinary CathetersSummary page 2…Bard 4-Way Catheter Bard Latex Urinary Bard Hydrogel/Silver- Product (this 510(k)) Catheters Coated Foley Catheter Characteristic (Predicate device) (Predicate device) (#K922431) (#K910318) Indications or || The Bardex I.C. 4-Way Foley | Bard Catheters are intended The Bard Hydrogel/Silver- Intended Use ||… | 1993 |
| * | K910318 | Bard (R) Hydrogel/Silver-Coated Foley CatheterSummary page 2…Catheter Bard Latex Urinary Bard Hydrogel/Silver- Product (this 510(k)) Catheters Coated Foley Catheter Characteristic (Predicate device) (Predicate device) (#K922431) (#K910318) Indications or || The Bardex I.C. 4-Way Foley | Bard Catheters are intended The Bard Hydrogel/Silver- Intended Use || Catheter i… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
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. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures 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/K983101 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983101: Bardex I.C 4-Way Foley Catheter Model 1865SIXX XX = 18,20,22,24.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983101
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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