# Clearwater Colon Hydrotherapy, Inc.

- Location (FDA's records): Ocala, FL
- FDA decisions: 2 (1996–2000): 2 510(k) clearances
- Product codes: KPL (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 2 (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 that cite its devices most
- Transcendencias Comerciales SL Transcom: 1 (https://510kreport.com/company/transcendencias-comerciales-sl-transcom)
- Prime Pacific Health Innovations Corporation: 1 (https://510kreport.com/company/prime-pacific-health-innovations)

## Its most-cited devices
- K000388: Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small) (2000), cited by 2

## Recent decisions
- K000388: Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small) (Aug 8, 2000)
- K942867: Clearwater Colon Hydrotherapy Model PPC-101 (Jun 26, 1996)

Source page: https://510kreport.com/company/clearwater-colon-hydrotherapy