# K261266: MOWANA™ Auto Duo

- Pathway: 510(k) (Traditional)
- Applicant: Pentamaster Mediq SDN BHD
- Decided: Sep 17, 2026 after 154 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K051899 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223286: BD AutoShield Duo™ Pen Needle, Becton, Dickinson and Company (2022) Summary page 5.

## Indications for use
The hypodermic pen needle is intended to be used with pen injector device for subcutaneous injection of medications including but not limited to insulin. The device has a passive dual safety mechanism that activates to cover both ends of the pen needle upon use to prevent accidental needle stick injuries.

Source page: https://510kreport.com/device/K261266
Methodology: https://510kreport.com/methodology