# K101309: Exelint Aluminum Hub Blunt Needles

- Pathway: 510(k) (Traditional)
- Applicant: Exelint International, Co.
- Decided: Oct 20, 2010 after 163 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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: 1 generation back to K854547 (1986). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K854547: Monoject Sterile M200 Aluminum/M250 Polypropylene, Sherwood Medical Co. (1986) Summary page 1.

## Indications for use
The EXELINT Aluminum Hub Blunt Needles are intended to be used in a variety of medical, pharmaceutical and laboratory procedures to extract fluid or medication from vials or ampoule for transfer or for irrigation.

Source page: https://510kreport.com/device/K101309
Methodology: https://510kreport.com/methodology