# K040897: Dover Rob-Nel Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare
- Decided: Jul 20, 2004 after 105 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K810216 (1981). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K810216: Argyle Rob-Nels, Sherwood Medical Co. (1981) Summary page 1.

## Most influential descendants
- K183335: Medline Poly-Cath Red Polymer Urethral Catheter (2019), 0 descendants of its own

## Indications for use
The proposed device is intended for use in the drainage of urine from the urinary bladder. The product is intended for intermittent catheterization on patients who are not capable of voluntary urination. This product is not designed for use as an indwelling catheter.

Source page: https://510kreport.com/device/K040897
Methodology: https://510kreport.com/methodology