510(k) Report

FDA applicant

Bruce Franklin, Inc.

Mchenry, IL1 decision1982–19820 recalls

FDA records 1 decision for Bruce Franklin, Inc. (Mchenry, IL) in 1982: 1 510(k) clearance. All are in product code DXK (Echocardiograph). 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Bruce Franklin, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Bruce Franklin, 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 “Bruce”

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