# Custom Assemblies, Inc.

- Location (FDA's records): Mccordsville, IN
- FDA decisions: 1 (2000–2000): 1 510(k) clearance
- Product codes: FPA (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- R-Group Intl.: 1 (https://510kreport.com/company/r-group-intl)
- The Kipp Group: 1 (https://510kreport.com/company/kipp-group)

## Recent decisions
- K993463: Intravascular Administration Set (Jan 4, 2000)

Source page: https://510kreport.com/company/custom-assemblies