# K131950: Angel Tip Safety Intravascular Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Summit International Medical Technologies, Inc.
- Decided: Jan 16, 2015 after 568 days
- Product code: FIE (Needle, Fistula)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K010406 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912563: Angel Wing Safety Blood Collection and Infusion SE, Mbo Laboratories, Inc. (1991) Summary page 4.
- K111948: Wingeater V2, JMS North America Corporation (2011) Summary page 4.

## Indications for use
The Angel Tip Safety Intravascular Needle Set is indicated to access the peripheral vascular system for hemodialysis. Additionally, after withdrawal of the needle from the patient's vein, the needle can be manually retracted within a safety enclosure to minimize the risk of an accidental needle stick.

Source page: https://510kreport.com/device/K131950
Methodology: https://510kreport.com/methodology