# K973899: Unifine Pentips

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford USA, Inc.
- Decided: Dec 4, 1997 after 51 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
No predicates in its family tree.
47 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Microfine: named in the summary without a submission number

## Most influential descendants
- K033575: One.Click Needle (2004), 43 descendants of its own
- K080904: Feel-Fine Insulin Pen Needle (2008), 30 descendants of its own
- K112332: Fine Ject Insulin Pen Needle (2012), 21 descendants of its own
- K120690: Insulin Pen Needle (2012), 20 descendants of its own
- K133059: Insulin Pen Needle (2014), 18 descendants of its own

## Indications for use
The Unifine Pentip is single use, disposable hypodermic single lumen needle designed for use with multidose injection devices that use prefilled cartridges. The protective paper is removed from the Pentip which is then screwed onto the device cartridge housing and then used in the prescribed manner. One of the main uses of the Pentip is for use with pen Injectors for the delivery of insulin which is supplied in the form of prefilled cartridges. The patient places a fresh Pentip needle onto the Pen Injector, dials a dose, inserts the Pentip into the skin and delivers the dose.

Source page: https://510kreport.com/device/K973899
Methodology: https://510kreport.com/methodology