# K241385: Omnifix Syringe NRFit

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jul 13, 2024 after 59 days
- Product code: QEH (Piston Syringe With Neuraxial Connector – Epidural, Peripheral, And/Or Indirect Cerebral Spinal Fluid Contact  )
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K944355 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071459: B. Braun Piston Syringes and Omnican and Omnifix Insulin Syringes, B.Braun Medical, Inc. (2007) Summary page 4.

## Indications for use
The B. Braun Omnifix Syringe NRFit is intended for neuraxial use for aspiration/injection of fluids used by healthcare professionals in healthcare facilities.

Source page: https://510kreport.com/device/K241385
Methodology: https://510kreport.com/methodology