FDA applicant

Opap, Inc.

Pioneer, CA1 decision1999–19990 recalls

FDA records 1 decision for Opap, Inc. (Pioneer, CA) in 1999: 1 510(k) clearance. All are in product code BZD (Ventilator, Non-Continuous (Respirator)). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Opap, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Opap, Inc.’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

Opap, Inc.

Which product codes does it file in?

What has FDA decided for it lately?