# K130023: K100 Neutral Displacement Needle Free Connector

- Pathway: 510(k) (Traditional)
- Applicant: Np Medical, Inc.
- Decided: Apr 3, 2013 after 90 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Capless Luer Activated Valve: named in the summary without a submission number

## Most influential descendants
- K220288: NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector (2023), 0 descendants of its own

## Indications for use
The K100 Neutral Displacement Needle Free Connector isa single patient use device for needleless access to the IV line and/or IV catheter during IV therapy. The K100 connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

Source page: https://510kreport.com/device/K130023
Methodology: https://510kreport.com/methodology