FDA Product Code PLB: Multivariate Vital Signs Index
Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.
Leading manufacturers include Etiometry, Inc., Spass, Inc. and Algodx AB.
FDA 510(k) Cleared Multivariate Vital Signs Index Devices (Product Code PLB)
About Product Code PLB - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code PLB since 1985, with 8 receiving FDA clearance (average review time: 245 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under PLB have taken an average of 135 days to reach a decision - down from 282 days historically, suggesting improved FDA processing for this classification.
PLB devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →