# K122785: Hydrosil; Magic; Personal Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Rochester Medical Corp.
- Decided: May 14, 2013 after 245 days
- Product code: EZD (Catheter, Straight)
- 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: 4 generations back to K910022 (1991). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000723: Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic), Rochester Medical Corp. (2000) Summary page 1.
- K072808: Speedicath Compact, Coloplast Corp. (2007) Summary page 1.

## Most influential descendants
- K150345: Magic3 Go Intermittent Urinary Catheter (2015), 1 descendant of its own
- K172247: Magic3 Go Intermittent Urinary Catheter (2017), 0 descendants of its own

## Recalls of this device
- 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.

## Indications for use
For urological use only. Intended for use by patients for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.

Source page: https://510kreport.com/device/K122785
Methodology: https://510kreport.com/methodology