# K180725: Aspire Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Aspire Bariatrics, Inc.
- Decided: Jul 11, 2018 after 113 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K801941 (1980). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070449: Lumiloc (TM) Safety Introducer Needle, Specialized Health Products International, Inc. (2007) Summary page 4.
- K043258: Modified TFX Medical Safety Needle with Introducer, Part NO. T4634-02, Teleflex Medical (2004) Summary page 4.

## Indications for use
The Aspire Introducer Needle is intended to be used for guidewire introduction during percutancous gastrointestinal procedures.

Source page: https://510kreport.com/device/K180725
Methodology: https://510kreport.com/methodology