# K150381: Aqua Cleanse

- Pathway: 510(k) (Traditional)
- Applicant: Quality Medical Supply, Inc.
- Decided: Sep 11, 2015 after 205 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: 2 generations back to K970482 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131852: HC-1 and HC-1 Classic, Transcendencias Comerciales SL Transcom (2014) Summary page 4.
- (no number) Hydro kits: named in the summary without a submission number

## Most influential descendants
- K201861: Bio Fluff System (2022), 0 descendants of its own

## Indications for use
THIS DEVICE IS INTENDED FOR COLON CLEANSING WHEN MEDICALLY INDICATED, SUCH AS BEFORE RADIOLOGICAL OR ENDOSCOPIC EXAMINATION.

Source page: https://510kreport.com/device/K150381
Methodology: https://510kreport.com/methodology