# K060141: DAI-R

- Pathway: 510(k) (Traditional)
- Applicant: Shl Medical, USA
- Decided: Jun 12, 2006 after 144 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.
3 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)
- K050434: SHL Disposable Autoinjector, Shl Medical, USA (2005) Summary page 1.

## Most influential descendants
- 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
The DAI-RTM Autoinjector is a hand-held mechanical device intended for the automated, self-admihistration of FDA-approved drugs and biologics. The DAI-RTm Autoinjector is designed to be used with a standard Glass Barrel lmL Long Syringe with Luer Lock Tip that has been prefilled prior to an injection. The DAI-RTM Autoinjector is for use in the home environment to aid and support prescribed treatment and therapy.

Source page: https://510kreport.com/device/K060141
Methodology: https://510kreport.com/methodology