# K990428: Drainage Bag

- Pathway: 510(k) (Traditional)
- Applicant: Remington Medical, Inc.
- Decided: Aug 12, 1999 after 182 days
- Product code: EXF (Bag, Bile Collecting)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- Nov 3, 2023 · Class II · Z-0487-2024: There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
- Jul 23, 2007 · Not classified · Z-0058-2008: Sterility, inadequate -- Pathway may not be sterile as labeled.

## Indications for use
Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection.

Source page: https://510kreport.com/device/K990428
Methodology: https://510kreport.com/methodology