# K012168: Advance Medical Designs Fluid Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Advance Medical Designs, Inc.
- Decided: Sep 18, 2001 after 68 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Advance Medical Designs Fluid Pouch is a body fluid drainage device. The Fluid Pouch is used for Hysteroscopy, Cystoscopy, Urelogy, and Brachytherapy procedures.

Source page: https://510kreport.com/device/K012168
Methodology: https://510kreport.com/methodology