# PPW: Adjunctive Cardiovascular Status Indicator

- Device class: 2; regulation: 21 CFR 870.2200; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 260 days (middle half 219–264)
- 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)
- 2016: 1
- 2018: 1
- 2022: 2
- 2023: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K213230: T3 Platform Software (2022), cited by 3
- DEN160020: CipherOx CRI Tablet (2016), cited by 2
- K223578: T3 Platform software (2023), cited by 1
- K241479: Etiometry Platform (DAV 5.4 RAE 9.2) (2025), cited by 1
- K173929: CipherOx CRI M1 (2018), cited by 1

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