# PLB: Multivariate Vital Signs Index

- Device class: 2; regulation: 21 CFR 870.2300; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 135 days (middle half 124–220)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1985: 1
- 2015: 1
- 2016: 1
- 2019: 1
- 2023: 2
- 2024: 2

## Most-cited predicates
- K183282: Biovitals Analytics Engine (2019), cited by 1
- K230386: SpassageQ (2023), cited by 1
- K152258: T3 Software (2016), cited by 1
- K142512: Personalized Physiology Analytics Engine software (2015), cited by 1
- K213423: T3 Platform software (2023), cited by 1

Source page: https://510kreport.com/product-code/PLB
Data by year (CSV): https://510kreport.com/product-code/PLB.csv