# K033477: Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System Kit

- Pathway: 510(k) (Traditional)
- Applicant: Rochester Medical Corp.
- Decided: Jun 10, 2004 after 220 days
- Product code: MJC (Catheter, Urological (Antimicrobial) And Accessories)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973120 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001143: Release NF Antibacterial Foley Catheter, Antibacterial Personal Catheter, Rochester Medical Corp. (2000)
- K000723: Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic), Rochester Medical Corp. (2000) Summary page 1.
- K003873: Mentor Self-Cath Closed System, Mentor Corp. (2001) Summary page 1.
- K013483: Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus Kit, Hollister, Inc. (2002) Summary page 1.
- K010420: Rusch MMG/O'neil Catheter, Rusch, Inc. (2001) Summary page 1.

## Recalls of this device
- Jul 28, 2017 · Class II · Z-3226-2017: Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.
- Oct 5, 2016 · Class II · Z-0600-2017: 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: 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 F

## Indications for use
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.

Source page: https://510kreport.com/device/K033477
Methodology: https://510kreport.com/methodology