# K082587: Auto-Safety Injector-2 (Asi-2)

- Pathway: 510(k) (Traditional)
- Applicant: Medical House Products Limited
- Decided: Oct 2, 2008 after 24 days
- Product code: KZH (Introducer, Syringe Needle)
- Device class: 2
- Regulation: 21 CFR 880.6920
- 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 K000482 (2000). 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)
- K073476: Compact Auto-Safety Injector (Casi), Medical House (Asi) Limited (2008) Summary page 1.

## Indications for use
The Auto Safety Injector 2 (ASI-2) is indicated for assisting the self-administered subcutaneous injection of fixed doses of FDA-approved drug products with non-viscous (aqueous) liquid formulations, which are presented in standard Iml long BD Hypak® pre- filled syringes (PFS) with staked needles. The ASI-2 is primarily intended for home use by patients to aid and support their treatment regime or may be used by Health Care Professionals or caregivers.

Source page: https://510kreport.com/device/K082587
Methodology: https://510kreport.com/methodology