510(k) Report

FDA applicant

Sa3, LLC

Los Angeles, CA2 decisions2020–20251 recall

FDA records 2 decisions for Sa3, LLC (Los Angeles, CA) from 2020 to 2025: 2 510(k) clearances. All are in product code OLR (Oral Wound Dressing). Its devices cite 2 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

How often FDA has decided Sa3, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020: 12025: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2020high 1 (2022) · low 0 (2020)2026

Class I Class II/III not classified

FIG. 1 — Sa3, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OLROral Wound Dressing2decisions

Whose devices does it build on?

Its devices cite 2 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.

  • K202000Silatrix Oral GelSa3, LLC · 20201cites it

What has FDA decided for it lately?

  • K252425Silatrix Oral GelSa3, LLC · 2025
  • K202000Silatrix Oral GelSa3, LLC · 20201 recall

All 2 as Sa3, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K202000Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gmFeb 21, 2022Class II