# PTI: Non-Coring (Huber) Needle

- Device class: 2; regulation: 21 CFR 880.5570; FDA's rule: 510(k) required
- FDA decisions: 14
- 510(k) review time 2021–2025: median 131 days (middle half 95–186)
- 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: 5
- 2021: 2
- 2022: 1
- 2023: 1
- 2024: 1
- 2025: 3
- 2026: 1

## Most-cited predicates
- K200463: Huber Needle Infusion Set, Safety Huber Needle Infusion Set (2021), cited by 2
- K170897: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (2017), cited by 2
- K171735: PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set (2017), cited by 1
- K230715: Promisemed Safety Huber Needle (2023), cited by 1
- K162271: Pro-Lock CT Safety Infusion Set (2017), cited by 1
- K243332: Promisemed Safety Huber Needles (2025), cited by 1

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