FDA applicant
Copal, Inc.
FDA records 5 decisions for Copal, Inc. (Mchenry, IL) from 1982 to 1984: 5 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). 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 Copal, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Copal, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Copal, 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