# K161812: Freedom Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Procedure Products, Inc.
- Decided: Mar 27, 2017 after 269 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: 4 generations back to K980580 (1998). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103736: DMC Medical Single-Use Polycarbonate Syringe, Dmc Medical, Ltd. (2011) Summary page 5.

## Indications for use
The Freedom™ Syringe is intended to inject fluids into, or withdraw fluids from, the body.

Source page: https://510kreport.com/device/K161812
Methodology: https://510kreport.com/methodology