# R-Group Intl.

- Location (FDA's records): Gainesville, FL
- FDA decisions: 7 (1992–2000): 7 510(k) clearances
- Product codes: FPA (3), GCD (1), HGI (1), DRC (1), CBT (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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 that cite its devices most
- Custom Assemblies, Inc.: 1 (https://510kreport.com/company/custom-assemblies)

## Its most-cited devices
- K940319: R-Group International Coiled Low Pressure Extension Line (1994), cited by 1

## Recent decisions
- K001233: Acti-Flex Fluid Delivery System or Acti-Flex F D S (Dec 13, 2000)
- K001599: Acti-Flex IV Administration Set (Sep 18, 2000)
- K993777: Disposable and Reusable Ball and Loop Electrodes (May 25, 2000)
- K952470: Acti-Flex Low, Medium, Rescare I, Rescare II. (Nov 28, 1995)
- K954035: Acti-Flex Arterial Extension Set (Sep 25, 1995)
- K940319: R-Group International Coiled Low Pressure Extension Line (Nov 10, 1994)
- K913267: R-Group Intl. One Wall Puncture Needle (Jun 5, 1992)

Source page: https://510kreport.com/company/r-group-intl