# K140175: Intravascular Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Delta Med Spa
- Decided: Aug 5, 2014 after 194 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
Longest line of descent: 5 generations back to K970259 (1997). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070547: Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Terumo Europe N.V. (2007) Summary page 7.
- K100946: Intravscular Administration Set, Terumo Europe N.V. (2010) Summary page 7.

## Indications for use
The Delta Fly F20μ Micro Bore Winged Safety Needles and the Delta Fly Micro Bore Winged Safety Needles are intended for short term use to access the peripheral vascular system for intravenous administration of fluids using a syringe or other compatible / appropriate devices.

Source page: https://510kreport.com/device/K140175
Methodology: https://510kreport.com/methodology
