510(k) Report

510(k) · Cleared

Cleared

Angel of Water Colon Hydrotherapy System

K003720510(k) TraditionalCleared Jun 27, 2002570-day reviewClass II21 CFR 876.5220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lifestream Purfication Systems, LLC · KPL Colonic Irrigation System

Cleared on Jun 27, 2002 after a 570-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jun 27, 2002
Review
570 days
Class
Class II
Product code
KPL
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2010: 1 descendant cleared2005: 1 descendant cleared200020052010201520202025
  1. This deviceK003720 Angel of Water Colon Hydrotherapy SystemLifestream Purfication Systems, LLC · 2002
  2. Descendant · cites it directly · 1 of its ownK033149 Ultimate Professional Continuous Flow Colonic SystemUltimate Concepts, Inc. · 2004
  3. Descendant · cites it directly · 0 of its ownK094022 The Water LilyClearwater Products, LLC · 2010
  4. Descendant · 2 generations on · 0 of its ownK051344 Colonic and Enema NozzleUltimate Concepts, Inc. · 2005

Most influential descendants

Showing 3 of 3 · See all
  • K033149Ultimate Professional Continuous Flow Colonic SystemUltimate Concepts, Inc. · 2004 · cites it directly1descendant
  • K094022The Water LilyClearwater Products, LLC · 2010 · cites it directly0descendants
  • K051344Colonic and Enema NozzleUltimate Concepts, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003720Angel of Water Colon Hydrotherapy SystemLifestream Purfication Systems, LLC2002—
+1K033149Ultimate Professional Continuous Flow Colonic SystemUltimate Concepts, Inc.2004—
+1K094022The Water LilyClearwater Products, LLC2010—
+2K051344Colonic and Enema NozzleUltimate Concepts, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
201010
FIG. 1 — Lineage of K003720, 2002–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KPL device

  1. #1 K201861 Bio Fluff Systemscore 3.5 · 3 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033149Ultimate Professional Continuous Flow Colonic SystemUltimate Concepts, Inc.20041
K094022The Water LilyClearwater Products, LLC20100

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K033149 (Ultimate Concepts, Inc., 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KPL devices

KPL Colonic Irrigation System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPL

1in 2022

2007: 12010: 12014: 12015: 12016: 12018: 12022: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPL

Too few KPL 510(k)s in any year since 2007 to give a median.

Recalls per year · KPL

No recall names KPL since 2007.

Adverse event reports per year · KPL

1in 2017

2007: 22010: 22013: 12017: 1
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code KPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—02
20080—00
20090—00
20101—02
20110—00
20120—00
20130—01
20141—00
20151—00
20161—00
20170—01
20181—00
20190—00
20200—00
20210—00
20221—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in KPL

The KPL category page

  • K201861Bio Fluff SystemGnali Bocia S.R.L. · 2022
  • K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus · 2018
  • K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus…Colonplus Equipments & Speculums, S.L. · 2016
  • K150381Aqua CleanseQuality Medical Supply, Inc. · 2015
  • K131852HC-1 and HC-1 ClassicTranscendencias Comerciales SL Transcom · 2014

https://510kreport.com/device/K003720 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003720: Angel of Water Colon Hydrotherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003720

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026