FDA applicant
Cutter Laboratories, Inc.
FDA records 39 decisions for Cutter Laboratories, Inc. (Mchenry, IL) from 1976 to 1986: 39 510(k) clearances. Most are in product codes ELW (Material, Impression) and CAH (Filter, Bacterial, Breathing-Circuit). 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 Cutter Laboratories, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Cutter Laboratories, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Cutter Laboratories, 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