510(k) Report

FDA applicant

Altaviz, LLC

Irvine, CA3 decisions2022–20251 recall

FDA records 3 decisions for Altaviz, LLC (Irvine, CA) from 2022 to 2025: 3 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and QLY (Ophthalmic Syringe). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 176 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Altaviz, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2022: 12023: 12025: 1
2022high 1 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2022high 1 (2023) · low 0 (2022)2026

Class I Class II/III not classified

FIG. 1 — Altaviz, LLC by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • QLYOphthalmic Syringe1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 90 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 176 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K222681Altaviz Needle KitAltaviz, LLC · 20221cites it

What has FDA decided for it lately?

  • K243322Altaviz Intravitreal SyringeAltaviz, LLC · 2025
  • K231261Altaviz Needle Kit IIAltaviz, LLC · 2023
  • K222681Altaviz Needle KitAltaviz, LLC · 20221 recall

All 3 as Altaviz, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K222681Apellis Injection Kit 29g Injection Needle -single use intended to inject fluids into…Aug 22, 2023Class II