# PWH: Administrations Sets With Neuraxial Connectors

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 4
- 510(k) review time 2021–2025: median 310 days (middle half 245–376)
- 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)
- 2017: 1
- 2018: 1
- 2021: 1
- 2023: 1

## Most-cited predicates
- K162219: CADD® Infusion Disposables Portfolio with NRFit™ connectors (2017), cited by 1
- K172592: CADD Yellow High Volume Administration Set with NRFit connector (2018), cited by 1

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