# Luther Needlesafe Products, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 2 (2004–2013): 2 510(k) clearances
- Product codes: FPA (1), FOZ (1)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Luther Research Partners: 1 (https://510kreport.com/company/luther-research-partners)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Vascular Pathways, Inc.: 1 (https://510kreport.com/company/vascular-pathways)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)

## Firms that cite its devices most
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)
- Specialized Health Products International, Inc.: 1 (https://510kreport.com/company/specialized-health-products-international)

## Its most-cited devices
- K040527: Low Profile Luther Safety Huber (2004), cited by 2

## Recent decisions
- K130518: Mini-Midline Extended Dwell Safety Catheter (Apr 30, 2013)
- K040527: Low Profile Luther Safety Huber (Mar 26, 2004)

Source page: https://510kreport.com/company/luther-needlesafe-products