# K112137: Comfortglide Intermitent Catheter

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 26, 2011 after 31 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: 2 generations back to K000070 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951260: Urinary Intermittent Catheters W/O Hydromer Hydrophilic Lubricant, Biosearch Medical Products, Inc. (1995) Summary page 1.
- K013345: Incare Intermittent Catheter, Hollister, Inc. (2002) Summary page 1.
- (no number) Bard® Red Rubber All-Purpose Urethral Catheter: named in the summary without a submission number

## Indications for use
The ComfortGlide™ Intermittent Catheter is intended for use by adult and pediatric, male and female patients for draining urine from the bladder.

Source page: https://510kreport.com/device/K112137
Methodology: https://510kreport.com/methodology