510(k) Report

FDA applicant

Health Care International Assoc.

Villa Park, CA1 decision1997–19970 recalls

FDA records 1 decision for Health Care International Assoc. (Villa Park, CA) in 1997: 1 510(k) clearance. All are in product code HET (Laparoscope, Gynecologic (And Accessories)). Its devices cite 4 predicates, 0 of them its own earlier devices. 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Health Care International Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Health Care International Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Health Care International Assoc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • HETLaparoscope, Gynecologic (And Accessories)1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K962246Rigid Fiber Optic LaparoscopeHealth Care International Assoc. · 1997

The one decision as Health Care International Assoc. →