510(k) Report

FDA applicant

Digitcare Corp.

Beverly Hils, CA3 decisions1989–19920 recalls

FDA records 3 decisions for Digitcare Corp. (Beverly Hils, CA) from 1989 to 1992: 3 510(k) clearances. Most are in product codes LYY (Latex Patient Examination Glove) and FOZ (Catheter, Intravascular, Therapeutic…). 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 Digitcare Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Digitcare Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Digitcare Corp. 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?

  • LYYLatex Patient Examination Glove2decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

What has FDA decided for it lately?

  • K920700Seamless Latex Patient Exam GlovesDigitcare Corp. · 1992
  • K905009Digitcare I.V. Start KitDigitcare Corp. · 1990
  • K891491Seamless Latex Patient Examination GlovesDigitcare Corp. · 1989

All 3 as Digitcare Corp. →