510(k) · Cleared
ClearedSilicone Antibacterial Foley Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rochester Medical Corp. · MJC Catheter, Urological (Antimicrobial) And Accessories
Cleared on Jan 13, 1998 as substantially equivalent to K910318 (C.R. Bard, Inc., 1994) and 2 other predicates after a 256-day review. Its family tree reaches back 1 generation to 1987.
- Decided
- Jan 13, 1998
- Review
- 256 days
- Class
- Class II
- Product code
- MJC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K871429 (1987). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK871429 Antimicrobial Foley CatheterAmerican Pharmaseal Div. Ahsc · 1987
- This deviceK971627 Silicone Antibacterial Foley CatheterRochester Medical Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871429 | Antimicrobial Foley Catheter | American Pharmaseal Div. Ahsc | 1987 | — |
| 0 (this device) | K971627 | Silicone Antibacterial Foley Catheter | Rochester Medical Corp. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K910318 | Bard (R) Hydrogel/Silver-Coated Foley CatheterSummary page 1…ilicone Antibacterial Foley Catheter Predicate Device The predicate devices for purposes of substantial equivalence are the C.R. Bard Corp. Bardex® 1.C. Foley Cathcter (K910318), the Amcrican Pharmascal Co. Antimicrobial Foley Catheter (K871429) and the Rochester Medical All Silicone Foley Catheter (K896… | 1994 |
| * | K871429 | Antimicrobial Foley CatheterSummary page 1…devices for purposes of substantial equivalence are the C.R. Bard Corp. Bardex® 1.C. Foley Cathcter (K910318), the Amcrican Pharmascal Co. Antimicrobial Foley Catheter (K871429) and the Rochester Medical All Silicone Foley Catheter (K896053). Intended Use of the Device The Silicone Antibacterial Foley… | 1987 |
| * | K896053 | All Silicone Foley CatheterSummary page 1…d Corp. Bardex® 1.C. Foley Cathcter (K910318), the Amcrican Pharmascal Co. Antimicrobial Foley Catheter (K871429) and the Rochester Medical All Silicone Foley Catheter (K896053). Intended Use of the Device The Silicone Antibacterial Foley Catheter is intended for short term use to provide continuous uri… | 1990 |
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 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K910318.
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 Silicone Antibacterial Foley catheter is intended for short term use to provide continuous urinary bladder drainage in adult males and females requiring catheterization for surgical procedures, monitoring urine output, management of incontinence, and voiding dysfunction. The catheter has been shown to provide a statistically significant reduction in the incidence of catheter acquired bacterial urinary tract infection during the first 5 days of catheterization. This device is not intended to be used as a treatment for active urinary tract infections.
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/K971627 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971627: Silicone Antibacterial Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971627
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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