# Regulatory Insight, Inc.

- Location (FDA's records): Littleton, CO
- FDA decisions: 4 (2002–2014): 4 510(k) clearances
- Product codes: IOR (2), HIR (1), GEX (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Deschutes Medical Products, Inc.: 1 (https://510kreport.com/company/deschutes-medical-products)

## Recent decisions
- K140780: Kegel Smart, Kegelsmart Pearl (Sep 10, 2014)
- K112505: Etherea (Apr 6, 2012)
- K020094: EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 and EN 600-670 Mechanical Wheelchairs (Mar 8, 2002)
- K020100: SL 803, SL 804, SL 807, SL 809, SL 506, SL 501, SL 805 and SL 801 Mechanical Wheelchairs (Mar 8, 2002)

Source page: https://510kreport.com/company/regulatory-insight