510(k) Report

FDA applicant

Oti Medical, LLC

Sacramento, CA2 decisions1995–19950 recalls

FDA records 2 decisions for Oti Medical, LLC (Sacramento, CA) in 1995: 2 510(k) clearances. Most are in product codes HJO (Biomicroscope, Slit-Lamp, Ac-Powered) and HPC (Set, Lens, Trial, Ophthalmic). No 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Oti Medical, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oti Medical, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Oti Medical, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • HJOBiomicroscope, Slit-Lamp, Ac-Powered1decision
  • HPCSet, Lens, Trial, Ophthalmic1decision

What has FDA decided for it lately?

  • K951184Oti Model 78-60Oti Medical, LLC · 1995
  • K951437Oti Model TLS-60Oti Medical, LLC · 1995

All 2 as Oti Medical, LLC →