# K202432: MiniLoad Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Ocuject, LLC
- Decided: Feb 19, 2021 after 178 days
- Product code: FMF (Syringe, Piston)
- 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). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101547: Henke- Sass, Wolf Piston Syringe (Norm-Jet), Henke-Sass, Wolf GmbH (2010) Summary page 4.

## Most influential descendants
- K231558: SMB Luer lock disposable syringe (2024), 0 descendants of its own
- K212544: MiniLoad Syringe (2021), 0 descendants of its own

## Indications for use
The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K202432
Methodology: https://510kreport.com/methodology