# K970482: Transcom Colon Hydrotherapy Model HC-2000

- Pathway: 510(k) (Traditional)
- Applicant: Srs Intl.
- Decided: Oct 31, 1997 after 263 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Specialty Health Models A&B: named in the summary without a submission number
- (no number) Clearwater PPC-101: named in the summary without a submission number
- (no number) Dotolo Research Corp. Toxygen: named in the summary without a submission number

## Most influential descendants
- K131852: HC-1 and HC-1 Classic (2014), 4 descendants of its own
- 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 indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.

Source page: https://510kreport.com/device/K970482
Methodology: https://510kreport.com/methodology