# K973546: Kendall Fast-Cath Pre Lubricated Urethral Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
- Decided: Nov 7, 1997 after 50 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 K910022 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910022: MMG/O'neil Urinary Catheterization System Kit, Medical Marketing Group (1991) Summary page 1.
- (no number) Bard Touchless Plus Unisex Pre-Lubricated Urethral Catheter: named in the summary without a submission number

## Indications for use
Steril; intermittent Catheterization for Urine Drainage from the bladder.

Source page: https://510kreport.com/device/K973546
Methodology: https://510kreport.com/methodology