# K990777: Med-RX Extension Sets

- Pathway: 510(k) (Traditional)
- Applicant: Benlan, Inc.
- Decided: Aug 25, 1999 after 169 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) Medex Extension Sets, MX454-FL: named in the summary without a submission number
- (no number) Medex Extension Sets, MX448-1.36: named in the summary without a submission number
- (no number) Medex Extension Sets, 536040: named in the summary without a submission number

## Indications for use
These extension sets are sterile, single use, medical devices intended for use in LV, therapy when extended fluid path is required for fluid or drug administration. Benlan Inc. docs not cause or promhotc ncw intended uses for these devices.

Source page: https://510kreport.com/device/K990777
Methodology: https://510kreport.com/methodology