# Rochester Medical Corp.

- Location (FDA's records): Stewartville, MN
- FDA decisions: 14 (1990–2013): 13 510(k) clearances and 1 original PMA approval
- Product codes: MJC (3), EZL (3), GBM (2), KOD (2), EXJ (2), EZD (1), OCK (1)
- Predicates its devices cite: 12 (6 its own); citations of its devices by later devices: 14 (6 its own)
- Recalls linked to its devices: 37 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- American Pharmaseal Div. Ahsc: 1 (https://510kreport.com/company/american-pharmaseal-div-ahsc)
- Coloplast Corp.: 1 (https://510kreport.com/company/coloplast)
- Mentor Corp.: 1 (https://510kreport.com/company/mentor)
- Hollister, Inc.: 1 (https://510kreport.com/company/hollister)
- Rusch, Inc.: 1 (https://510kreport.com/company/rusch)

## Firms that cite its devices most
- C.R. Bard, Inc.: 3 (https://510kreport.com/company/cr-bard)
- Guangdong Baihe Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/guangdong-baihe-medical-technology)
- Cook Urological, Inc.: 1 (https://510kreport.com/company/cook-urological)
- Sewoon Medical Co., Ltd.: 1 (https://510kreport.com/company/sewoon-medical)
- Medical Device Intl., Inc.: 1 (https://510kreport.com/company/medical-device-intl)
- Well Lead Medical Instruments: 1 (https://510kreport.com/company/well-lead-medical-instruments)

## Its most-cited devices
- K000723: Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic) (2000), cited by 4
- K981612: All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter (1998), cited by 4
- K896053: All Silicone Foley Catheter (1990), cited by 2
- K943851: All Silicone Intermittent Catheter (1995), cited by 1
- K941692: Female Length All Silicone Urological Catheter (1995), cited by 1
- K122785: Hydrosil; Magic; Personal Catheter (2013), cited by 1

## Recent decisions
- K122785: Hydrosil; Magic; Personal Catheter (May 14, 2013)
- K033477: Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System Kit (Jun 10, 2004)
- K001143: Release NF Antibacterial Foley Catheter, Antibacterial Personal Catheter (Jul 7, 2000)
- K000723: Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic) (May 19, 2000)
- P990002: Femsoft Urethral Insert (Sep 30, 1999)
- K981612: All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter (Jul 8, 1998)
- K971627: Silicone Antibacterial Foley Catheter (Jan 13, 1998)
- K970704: Personal Catheter (Mar 13, 1997)

Source page: https://510kreport.com/company/rochester-medical