# K082616: Haselmeier Pen 8

- Pathway: 510(k) (Special)
- Applicant: Haselmeier GmbH
- Decided: Sep 26, 2008 after 17 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K905693 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070100: Haselmeier Pen, Haselmeier Sarl (2007) Summary page 1.

## Indications for use
The Haselmeier Pen 8 is a hand-held mechanical device intended for subcutaneous self-administration of FDA-approved drugs and biologics. The Haselmeier Pen 8 is designed to be used with 3.0 mL cartridges which are prefilled prior to injection. The Haselmeier Pen 8 is for use in the home environment to aid and support prescribed treatment and therapy.

Source page: https://510kreport.com/device/K082616
Methodology: https://510kreport.com/methodology