# K243322: Altaviz Intravitreal Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Altaviz, LLC
- Decided: May 9, 2025 after 198 days
- Product code: QLY (Ophthalmic Syringe)
- 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 5.

## Indications for use
The Altaviz Intravitreal Syringe is intended for use by heath care professionals for general purpose fluid aspiration/injection. It is indicated for general and intravitreal use in adult patients.

Source page: https://510kreport.com/device/K243322
Methodology: https://510kreport.com/methodology