# K063280: Injekt Syringe

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 17, 2006 after 17 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: 3 generations back to K944355 (1994). 3 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051574: Nipro Disposable Syringe with or Without Needle, Nipro Medical Corp. (2005)

## Most influential descendants
- K101547: Henke- Sass, Wolf Piston Syringe (Norm-Jet) (2010), 3 descendants of its own
- K071459: B. Braun Piston Syringes and Omnican and Omnifix Insulin Syringes (2007), 3 descendants of its own
- K202432: MiniLoad Syringe (2021), 2 descendants of its own
- K241385: Omnifix Syringe NRFit (2024), 0 descendants of its own
- K231558: SMB Luer lock disposable syringe (2024), 0 descendants of its own

## Recalls of this device
- Aug 7, 2023 · Class II · Z-2644-2023: The sterile blister packaging may be damaged, and sterility may be compromised
- Aug 7, 2023 · Class II · Z-2643-2023: The sterile blister packaging may be damaged, and sterility may be compromised

## Indications for use
The B. Braun lnjekt® piston syringes are intended to be used to inject fluid into, or withdraw fluids from, the body.

Source page: https://510kreport.com/device/K063280
Methodology: https://510kreport.com/methodology