# K020926: Extension Set, Models 1911-512

- Pathway: 510(k) (Traditional)
- Applicant: Epimed International, Inc.
- Decided: Jul 12, 2002 after 113 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Medical Systems Luer Lok Microbore Extension Set: named in the summary without a submission number
- (no number) Abbott Hospital Products Microbore Extension Set: named in the summary without a submission number

## Indications for use
The extension set is used to extend the length of another fluid or medication delivery device to provide continued fluid flow.

Source page: https://510kreport.com/device/K020926
Methodology: https://510kreport.com/methodology