FDA applicant

Ivac Corporation

San Diego2 decisions1987–19960 recalls

FDA records 2 decisions for Ivac Corporation (San Diego) from 1987 to 1996: 1 510(k) clearance and 1 original PMA approval. Most are in product codes LSX (Controller, Closed-Loop, Blood-Pressure) and LZH (Pump, Infusion, Enteral). 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 Ivac Corporation’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ivac Corporation since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ivac Corporation’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

Other applicant names beginning “Ivac”

FDA records each applicant name separately; these may or may not be the same firm.

Ivac Medical Systems 2

Ivac Corporation

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ivac”