# K173803: Omnican fine

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jun 11, 2018 after 178 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: 1 generation back to K152050 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152050: Pencylcap, B.Braun Melsungen AG (2016) Summary page 4.

## Indications for use
Omnican fine is intended for use with compatible needle-based injection systems for subcutaneous injection of fluid drug products.

Source page: https://510kreport.com/device/K173803
Methodology: https://510kreport.com/methodology