# K210399: Unifine SafeControl

- Pathway: 510(k) (Special)
- Applicant: Owen Mumford, Ltd.
- Decided: Sep 17, 2021 after 219 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: 3 generations back to K973899 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173881: Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G, Owen Mumford, Ltd. (2018) Summary page 5.

## Indications for use
The Unifine SafeControl™ range of pen needles are intended for use with multi-dose injection devices for the subcutaneous injection of FDA approved drugs, including insulin.

Source page: https://510kreport.com/device/K210399
Methodology: https://510kreport.com/methodology