# K152183: EXELINT SecureTouch Safety Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Exelint International, Co.
- Decided: Nov 2, 2015 after 89 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K010188 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123684: Sol-Care Safety Needle, Sol-Millennium Medical (2013) Summary page 4.

## Indications for use
EXELINT SecureTouch Safety Hypodermic Needle is intended for use with syringes for general purpose aspiration and medication administration. It has an antistick mechanism to cover the needle after use.

Source page: https://510kreport.com/device/K152183
Methodology: https://510kreport.com/methodology