# K153553: SiO2 Coated syringe 3 ml

- Pathway: 510(k) (Traditional)
- Applicant: Sio2 Medical Products
- Decided: May 17, 2016 after 158 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: 2 generations back to K980987 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110771: BD Single Use, Hypodermic Syringe, Becton, Dickinson and Company (2011) Summary page 4.

## Indications for use
The SiO2 Coated Syringe 3 mL is intended to be used to inject fluids into, or withdraw fluids from, the body.

Source page: https://510kreport.com/device/K153553
Methodology: https://510kreport.com/methodology