510(k) Report

FDA applicant

Output, Inc.

Mchenry, IL5 decisions1976–19800 recalls

FDA records 5 decisions for Output, Inc. (Mchenry, IL) from 1976 to 1980: 5 510(k) clearances. Most are in product codes DSK (Computer, Blood-Pressure) and GZI (Stimulator, Neuromuscular, External Functional). 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 Output, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Output, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Output, 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