# K212544: MiniLoad Syringe

- Pathway: 510(k) (Special)
- Applicant: Ocuject, LLC
- Decided: Oct 13, 2021 after 62 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: 6 generations back to K944355 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202432: MiniLoad Syringe, Ocuject, LLC (2021) Summary page 4.

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

Source page: https://510kreport.com/device/K212544
Methodology: https://510kreport.com/methodology