# K070100: Haselmeier Pen

- Pathway: 510(k) (Traditional)
- Applicant: Haselmeier Sarl
- Decided: Mar 21, 2007 after 70 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: 3 generations back to K905693 (1991). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060141: DAI-R, Shl Medical, USA (2006) Summary page 1.
- K982966: Disetronic Pen, Disetronic Medical Systems (1998) Summary page 1.
- K982842: Humapen and Humapen Ergo, Eli Lilly and Co. (1998) Summary page 1.

## Most influential descendants
- K083457: Tactipen (2009), 0 descendants of its own
- K082616: Haselmeier Pen 8 (2008), 0 descendants of its own

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

Source page: https://510kreport.com/device/K070100
Methodology: https://510kreport.com/methodology