# K050434: SHL Disposable Autoinjector

- Pathway: 510(k) (Traditional)
- Applicant: Shl Medical, USA
- Decided: Jun 24, 2005 after 122 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: 1 generation back to K000482 (2000). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000482: Modification to Autoject Mini, Owen Mumford, Ltd. (2000) Summary page 1.

## Most influential descendants
- K060141: DAI-R (2006), 3 descendants of its own
- K070100: Haselmeier Pen (2007), 2 descendants of its own
- K083457: Tactipen (2009), 0 descendants of its own
- K082616: Haselmeier Pen 8 (2008), 0 descendants of its own

## Indications for use
DAITM is a hand-held mechanical device intended for the automated, subcutaneous, self-administration of FDA-approved drugs and biologics. DAITM is designed to be used with the standard 1.OmL Long (glass) Syringe with Needle that has been prefilled prior to an injection. DAITM is for use in the home environment to aid and support prescribed treatment and therapy.

Source page: https://510kreport.com/device/K050434
Methodology: https://510kreport.com/methodology