510(k) Report

FDA applicant

Ventrex, Inc.

Ventura, CA6 decisions1992–20060 recalls

FDA records 6 decisions for Ventrex, Inc. (Ventura, CA) from 1992 to 2006: 6 510(k) clearances. Most are in product codes DHB (System, Test, Radioallergosorbent (Rast)…) and HFM (Monitor, Uterine Contraction, External (For…). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Ventrex, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, immunology panel, where it files most

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

FDA decisions per year

No FDA decision for Ventrex, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ventrex, Inc.’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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Other applicant names beginning “Ventrex”

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