# K990500: Kendall Ultramer Coude Foley Catheter, Model 1416C, Kendall Curity Coude Foley Catheter Tray, Model 6946C

- Pathway: 510(k) (Abbreviated)
- Applicant: The Kendal Co.
- Decided: Sep 28, 1999 after 223 days
- Product code: EZL (Catheter, Retention Type, Balloon)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910195 (1991). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910195: Bard Hydrogel-Coated Foley Catheters, C.R. Bard, Inc. (1991) Summary page 1.

## Most influential descendants
- K042110: Beamcath (2005), 3 descendants of its own
- K131655: Lighthouse (TM) Urinary Catheter (2013), 1 descendant of its own
- K140099: Lighthouse Urinary Catheter (2014), 0 descendants of its own
- K082919: UC-Care Positioning System (2008), 0 descendants of its own
- K061661: Sta Cath Attachable Infision Catheter, Model STA20 (2006), 0 descendants of its own

## Recalls of this device
- Dec 4, 2023 · Class I · Z-1050-2024: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

## Indications for use
The Kendall Coude Foley Catheter is a urological catheter designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage.

Source page: https://510kreport.com/device/K990500
Methodology: https://510kreport.com/methodology