510(k) Report

Devices descending from K000388

6 later devices reach Clearwater Colon Hydrotherapy (Disposable Speculum SPO1 Large & SP02 Small) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131852HC-1 and HC-1 ClassicTranscendencias Comerciales SL Transcom20144—
+1K050112Pro Fit Disposable Rectal Speculum, Models 8116 and 8117Prime Pacific Health Innovations Corporation20051—
+2K180800Colonic Plus Regular, Small, and Straight Shape HydrokitColonic Plus20180—
+2K152834Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar…Colonplus Equipments & Speculums, S.L.20160—
+2K150381Aqua CleanseQuality Medical Supply, Inc.20151—
+3K201861Bio Fluff SystemGnali Bocia S.R.L.20220—