# K895890: Autopen

- Pathway: 510(k) (Traditional)
- Applicant: Ulster Scientific, Inc.
- Decided: Feb 16, 1990 after 134 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
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983974: Owen Mumford 3ML Autopen (1998), 7 descendants of its own
- K063151: Humapen Luxura HD (2007), 5 descendants of its own
- K100988: Humapen Luxura HD (2010), 4 descendants of its own
- K142518: HumaPen Luxura (2015), 3 descendants of its own
- K160668: HumaPen Savvio (2016), 1 descendant of its own

Source page: https://510kreport.com/device/K895890
Methodology: https://510kreport.com/methodology