# K062865: Small Volume Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Aug 23, 2007 after 332 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: 1 generation back to K941562 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941562: 1ML Luer-Lok Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

## Indications for use
The Small Volume Syringe is a 200 pl syringe used to inject fluids into, or withdraw fluids from, the body, ports and I.V. lines.

Source page: https://510kreport.com/device/K062865
Methodology: https://510kreport.com/methodology