FDA applicant
Output, Inc.
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
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.
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