# K990331: Surgen Valve

- Pathway: 510(k) (Traditional)
- Applicant: Tiva Medical
- Decided: May 31, 2000 after 484 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Continuous or intermittent multiple access connection port between IV devices such as patient access sites, catheters, syringes, or IV administrations sets. The sharps injury prevention feature of this device is the elimination of the need for a needle. The device (valve) is activated by inserting a standard male lucr on the end of marketed I.V. administration sets and syringes into the proximal end of the SurgeN.

Source page: https://510kreport.com/device/K990331
Methodology: https://510kreport.com/methodology