FDA applicant
Rule Medical Instruments, Inc.
FDA records 4 decisions for Rule Medical Instruments, Inc. (Mchenry, IL) from 1977 to 1979: 4 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and CCL (Analyzer, Gas, Oxygen, Gaseous-Phase). 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 Rule Medical Instruments, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Rule Medical Instruments, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Rule Medical Instruments, 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