DeviceClearance

Product code NDC— Anesthesiology

Insulia Diabetes Management Companion

Classification name
Calculator, Drug Dose
Device class
Class 2
Regulation
21 CFR 868.1890
Advisory panel
Anesthesiology
Total cleared
55
First cleared
Most recent

Market context for product code NDC

FDA has cleared 55 devices under product code NDC between 1986 and 2026, filed by 39 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NDC

Adverse events under product code NDC

product code NDC
Malfunction
1,390
Total
1,390

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NDC

Data sourced from openFDA. This site is unofficial and independent of the FDA.