# K071459: B. Braun Piston Syringes and Omnican and Omnifix Insulin Syringes

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Aug 16, 2007 after 83 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K944355 (1994). 7 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063280: Injekt Syringe, B.Braun Medical, Inc. (2006) Summary page 1.
- K051574: Nipro Disposable Syringe with or Without Needle, Nipro Medical Corp. (2005)
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1996) Summary page 1.
- K024112: BD Insulin Syringe, Becton, Dickinson & CO (2003) Summary page 1.

## Most influential descendants
- K241385: Omnifix Syringe NRFit (2024), 0 descendants of its own
- K193101: Omnifix Low Dead Space Luer Lock Syringe (2020), 0 descendants of its own
- K120127: Swan Valley Medical Tranurethral Suprapubic Endo-Cystostomy (T-Spec) Surgical System (2012), 0 descendants of its own

## Recalls of this device
- Aug 1, 2008 · Not classified · Z-2250-2009: I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package. Used to provide an optional filling device for the Easypump.
- Aug 1, 2008 · Not classified · Z-2249-2009: I-Flow identified a B. Braun syringe package that had a tear/hole in the paper portion of the primary package.

## Indications for use
The B. Braun Omnican® and Omnifix® Insulin Syringes are intended for subcutaneous injection of insulin. The B. Braun Omnifix® Piston Syringes are intended to be used to inject fluid into, or withdraw fluids from, the body.

Source page: https://510kreport.com/device/K071459
Methodology: https://510kreport.com/methodology