# K173881: Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford, Ltd.
- Decided: Jul 11, 2018 after 202 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: 2 generations back to K973899 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152339: Unifine Pentips/ Unifine Pentips Plus, Owen Mumford, Ltd. (2016) Summary page 5.

## Most influential descendants
- K210399: Unifine SafeControl (2021), 0 descendants of its own

## 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/K173881
Methodology: https://510kreport.com/methodology