FDA Product Code NDC: Calculator, Drug Dose
Leading manufacturers include Voluntis Sa., Welldoc, Inc. and Medtronic Minimed.
FDA 510(k) Cleared Calculator, Drug Dose Devices (Product Code NDC)
About Product Code NDC - Regulatory Context
510(k) Submission Activity
54 total 510(k) submissions under product code NDC since 1986, with 54 receiving FDA clearance (average review time: 158 days).
Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NDC have taken an average of 82 days to reach a decision - down from 169 days historically, suggesting improved FDA processing for this classification.
NDC devices are reviewed by the Chemistry panel. Browse all Chemistry devices →