# Altaviz, LLC

- Location (FDA's records): Irvine, CA
- FDA decisions: 3 (2022–2025): 3 510(k) clearances
- Product codes: FMI (2), QLY (1)
- 510(k) review time since 2016: median 90 days, against 176 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Tsk Laboratory, Japan: 1 (https://510kreport.com/company/tsk-laboratory-japan)
- Terumo Europe N.V.: 1 (https://510kreport.com/company/terumo-europe)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Its most-cited devices
- K222681: Altaviz Needle Kit (2022), cited by 1

## Recent decisions
- K243322: Altaviz Intravitreal Syringe (May 9, 2025)
- K231261: Altaviz Needle Kit II (Jul 27, 2023)
- K222681: Altaviz Needle Kit (Dec 5, 2022)

Source page: https://510kreport.com/company/altaviz