# K983974: Owen Mumford 3ML Autopen

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford USA, Inc.
- Decided: Dec 21, 1998 after 42 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895890 (1990). 1 ancestor in all.
7 later devices descend from it; 2 cite 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)
- K895890: Autopen, Ulster Scientific, Inc. (1990) Summary page 1.

## Most influential descendants
- 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
- K250262: GO-PEN® (2025), 0 descendants of its own

## Recalls of this device
- Dec 11, 2014 · Class II · Z-2082-2015: The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0. As a result, the patient could not dial up a dose of medicine to deliver via an injection.

## Indications for use
The delivery of insulin products using a variable dose pen for insulin dependent diabetics. The Owen Mumford 3ml Autopen is a non-sterile automatic subcutaneous injection device which uses a replaceable 3ml insulin cartridge held within the body of the device. An automatic drive system is used to displace the insulin from the cartridge through a sterile disposable needle.

Source page: https://510kreport.com/device/K983974
Methodology: https://510kreport.com/methodology