# K980127: 6 Inch Mini-Bone Extension Set with Luer Lock, NES01S, 6 Inch Min-Bone Extension Set with Luer Slip, NES02S, 6 Inch Stat

- Pathway: 510(k) (Traditional)
- Applicant: Catheter Innovations, Inc.
- Decided: Mar 11, 1998 after 56 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
These extension sets are indicated for needle-free use in the intravenous delivery of fluids, including but not limited to, hydration fluids, chemotherapy, antibiotics, analgesics, and nutritional therapy. The sets are commonly connected to the external portion of indwelling vascular access catheters.

Source page: https://510kreport.com/device/K980127
Methodology: https://510kreport.com/methodology