510(k) Report

FDA applicant

Medical Hospital Equipment

Chula Vista, CA3 decisions1985–19860 recalls

FDA records 3 decisions for Medical Hospital Equipment (Chula Vista, CA) from 1985 to 1986: 3 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and FMF (Syringe, Piston). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Medical Hospital Equipment since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medical Hospital Equipment by year, 2007–2026Sources: 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 Lumen1decision
  • FMFSyringe, Piston1decision
  • FPASet, Administration, Intravascular1decision

What has FDA decided for it lately?

  • K852616Mirage Intravenous Infusion Set Olovson-SterileMedical Hospital Equipment · 1986
  • K852615R.R. Aghi Hypodermic Single Lumen NeedleMedical Hospital Equipment · 1986
  • K852503R.R. Pronto SiringaMedical Hospital Equipment · 1985

All 3 as Medical Hospital Equipment →