# K072997: Neomed Urinary Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Neomed, Inc.
- Decided: Dec 19, 2007 after 56 days
- Product code: EZD (Catheter, Straight)
- 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 K944782 (1994). 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)
- K944782: Catco Urological Catheter, Catco Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K202566: Wiygul Catheter (2020), 0 descendants of its own

## Indications for use
The NeoMed Urinary Catheter is intended for use in neonatal and pediatric patients to sample urine and/or facilitate urinary drainage. This catheter is NOT a Foley (balloon) type catheter. This catheter is intended for temporary use and will be in contact with the patient for less than 30 days.

Source page: https://510kreport.com/device/K072997
Methodology: https://510kreport.com/methodology