# K000723: Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic)

- Pathway: 510(k) (Traditional)
- Applicant: Rochester Medical Corp.
- Decided: May 19, 2000 after 74 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 26 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
11 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070508: Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR (2007), 6 descendants of its own
- K091699: Amsure Hydrophilic Latex Foley Catheter (2009), 4 descendants of its own
- K162989: Rusch Simplastic Foley Catheters (2017), 2 descendants of its own
- K122785: Hydrosil; Magic; Personal Catheter (2013), 2 descendants of its own
- K212077: Teleflex Rusch SoftSimplastic Foley Catheters (2023), 1 descendant of its own

## Recalls of this device
- Jun 25, 2026 · Class II · Z-3117-2026: Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
- Jan 27, 2022 · Class II · Z-0666-2022: There is a potential to leak from the catheter where it connects to the drain bag
- Jan 27, 2022 · Class II · Z-0667-2022: There is a potential to leak from the catheter where it connects to the drain bag
- Sep 14, 2017 · Class II · Z-1307-2018: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
- Sep 14, 2017 · Class II · Z-1308-2018: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
- Sep 14, 2017 · Class II · Z-1309-2018: Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed.
- Aug 24, 2015 · Class II · Z-2732-2015: Potential breach of the sterile barrier packaging.
- Jul 7, 2015 · Class II · Z-2385-2015: Potential breach of the sterile barrier packaging.
- Jul 7, 2015 · Class II · Z-2384-2015: Potential breach of the sterile barrier packaging.
- Jul 7, 2015 · Class II · Z-2386-2015: Potential breach of the sterile barrier packaging.
- Jul 7, 2015 · Class II · Z-2387-2015: Potential breach of the sterile barrier packaging.
- Jul 7, 2015 · Class II · Z-2388-2015: Potential breach of the sterile barrier packaging.
- Jan 14, 2009 · Not classified · Z-1086-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1087-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1077-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1076-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1081-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1083-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1080-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1074-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1085-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1075-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1082-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1078-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1084-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.
- Jan 14, 2009 · Not classified · Z-1079-2009: Rochester Medical observed some Magic3 and HydroSil(R) catheter packages in which the catheter was caught in the package seal during the packaging process.

Source page: https://510kreport.com/device/K000723
Methodology: https://510kreport.com/methodology