# OKC: Implanted Subcutaneous Securement Catheter

- Device class: 2; regulation: 21 CFR 880.5970; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 41 days (middle half 41–41)
- 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)
- 2008: 1
- 2009: 1
- 2012: 1
- 2018: 1
- 2021: 1

## Most-cited predicates
- K082047: Securacath Catheter, Model SPK01 (2008), cited by 2
- K120935: Securacath (2012), cited by 1
- K083081: Modification to Securacath, Model: SPK01 (2009), cited by 1
- K180769: SecurAcath (2018), cited by 1

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