# K083457: Tactipen

- Pathway: 510(k) (Traditional)
- Applicant: Haselmeier GmbH
- Decided: Feb 13, 2009 after 84 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.
- K982966: Disetronic Pen, Disetronic Medical Systems (1998) Summary page 1.
- K982842: Humapen and Humapen Ergo, Eli Lilly and Co. (1998) Summary page 1.

## Indications for use
The TactiPen is a self injection device intended for the subcutaneous injection of U-100 insulin from a 3-mL cartridge.

Source page: https://510kreport.com/device/K083457
Methodology: https://510kreport.com/methodology