510(k) Report

FDA applicant

Bourns Medical Systems, Inc.

Mchenry, IL9 decisions1978–19800 recalls

FDA records 9 decisions for Bourns Medical Systems, Inc. (Mchenry, IL) from 1978 to 1980: 9 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and CAF (Nebulizer (Direct Patient Interface)). 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 Bourns Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bourns Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bourns Medical Systems, 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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