# K131852: HC-1 and HC-1 Classic

- Pathway: 510(k) (Traditional)
- Applicant: Transcendencias Comerciales SL Transcom
- Decided: Apr 17, 2014 after 300 days
- Product code: KPL (Colonic Irrigation System)
- Device class: 2
- Regulation: 21 CFR 876.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K970482 (1997). 2 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970482: Transcom Colon Hydrotherapy Model HC-2000, Srs Intl. (1997) Summary page 1.
- K000388: Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small), Clearwater Colon Hydrotherapy, Inc. (2000) Summary page 2.

## Most influential descendants
- K150381: Aqua Cleanse (2015), 1 descendant of its own
- K201861: Bio Fluff System (2022), 0 descendants of its own
- K180800: Colonic Plus Regular, Small, and Straight Shape Hydrokit (2018), 0 descendants of its own
- K152834: Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 (2016), 0 descendants of its own

## Indications for use
The use of this device is restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

Source page: https://510kreport.com/device/K131852
Methodology: https://510kreport.com/methodology