510(k) · Cleared
Recalled · Class II · 2017Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System Kit
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 Jun 10, 2004 as substantially equivalent to K001143 (Rochester Medical Corp., 2000) and 4 other predicates after a 220-day review. Its family tree reaches back 2 generations to 1998. It has been recalled 3 times.
- Decided
- Jun 10, 2004
- Review
- 220 days
- Class
- Class II
- Product code
- MJC
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 2 generations to K973120 (1998). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK973120 Readycath CatheterMedical Technologies of Georgia · 1998
- 1 generation backK013483 Incare Advance; Intermittent Catheter, Plus Intermittent Catheter…Hollister, Inc. · 2002
- This deviceK033477 Hydrophilic-Antibacterial Intermittent Catheter, Intermittent…Rochester Medical Corp. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973120 | Readycath Catheter | Medical Technologies of Georgia | 1998 | — |
| −1 | K013483 | Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit | Hollister, Inc. | 2002 | — |
| 0 (this device) | K033477 | Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed… | Rochester Medical Corp. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2001 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K001143 | Release NF Antibacterial Foley Catheter, Antibacterial Personal Catheter | 2000 |
| * | K000723 | Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and…Summary page 1…Closed System Kit Predicate Devices: Rochester Medical Antibacterial Personal®Catheter KOO1 143 Rochester Medical Hydrophilic Personal® Catheter K000723 Mentor Self-Cath Closed System K003873 Hollister InCare Advance Plus Kit K013483 Rusch MMG/O'Neil Cathete… | 2000 |
| * | K003873 | Mentor Self-Cath Closed SystemSummary page 1…Rochester Medical Antibacterial Personal®Catheter KOO1 143 Rochester Medical Hydrophilic Personal® Catheter K000723 Mentor Self-Cath Closed System K003873 Hollister InCare Advance Plus Kit K013483 Rusch MMG/O'Neil Catheter K010420 Intended Use of the Device… | 2001 |
| * | K013483 | Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitSummary page 1…theter KOO1 143 Rochester Medical Hydrophilic Personal® Catheter K000723 Mentor Self-Cath Closed System K003873 Hollister InCare Advance Plus Kit K013483 Rusch MMG/O'Neil Catheter K010420 Intended Use of the Device Hydrophilic-Antibacterial Intermittent C… | 2002 |
| * | K010420 | Rusch MMG/O'neil CatheterSummary page 1…Hydrophilic Personal® Catheter K000723 Mentor Self-Cath Closed System K003873 Hollister InCare Advance Plus Kit K013483 Rusch MMG/O'Neil Catheter K010420 Intended Use of the Device Hydrophilic-Antibacterial Intermittent Catheter… | 2001 |
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 |
|---|---|---|---|---|
| Jul 28, 2017 | Class II | Z-3226-2017 | Employee error | Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating. |
| Oct 5, 2016 | Class II | Z-0600-2017 | Mixed-up of materials/components | Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating). |
| Oct 2, 2015 | Class III | Z-0198-2016 | Error in labeling | Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 7 ancestors have 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?
Urethral catheter for urological use only. The Rochester Medical Corporation Hydrophilic-Antibacterial Intermittent Catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures. Efficacy of the Hydrophilic-Antibacterial Intermittent Catheter in preventing urinary tract infection during intermittent use has not been established. The device is not intended to be used as a treatment for active urinary tract infection.
For urological use only. The Intermittent Catheter Closed System Kit is intended for use by patients for the purpose of bladder drainage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033477: Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033477
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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