# K152339: Unifine Pentips/ Unifine Pentips Plus

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford, Ltd.
- Decided: Jun 24, 2016 after 310 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973899 (1997). 1 ancestor in all.
2 later devices descend 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)
- K973899: Unifine Pentips, Owen Mumford USA, Inc. (1997) Summary page 4.

## Most influential descendants
- K173881: Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G (2018), 1 descendant of its own
- K210399: Unifine SafeControl (2021), 0 descendants of its own

## Recalls of this device
- May 26, 2021 · Class II · Z-2078-2021: Mixed Up. Two (2) cases of Unifine Pentips Plus 4mm pen needles have been mixed into a packed configuration of Unifine Pentips Plus 8mm pen needles.
- Nov 6, 2017 · Class II · Z-0382-2018: Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
- Nov 6, 2017 · Class II · Z-0381-2018: Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.

## Indications for use
The Unifine Pentips range of pen needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin.

Source page: https://510kreport.com/device/K152339
Methodology: https://510kreport.com/methodology