# K240514: AMT Low-Profile Suprapubic Catheter & Drainage Set

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Nov 1, 2024 after 253 days
- Product code: KOB (Catheter, Suprapubic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K810368 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181097: Cook Cystostomy Catheter Set, Cook Incorporated (2019) Summary page 5.

## Indications for use
The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated for patients 7 years of age and older with lower urinary tract dysfunctions such as neurogenic bladder dysfunction, congenital malformation or urethral obstruction, or who are severely disabled or requiring constant care. The AMT Low-Profile Suprapubic Catheter & Drainage Set is indicated to be used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks. The AMT Low- Profile Suprapubic Catheter is intended to be placed directly into the bladder through a secured (initial placement) or formed (replacement) stoma.

Source page: https://510kreport.com/device/K240514
Methodology: https://510kreport.com/methodology