Product code KPL— Gastroenterology, Urology
JIMMY JOHN III
- Classification name
- Colonic Irrigation System
- Device class
- Class 2
- Regulation
- 21 CFR 876.5220
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 40
- First cleared
- Most recent
Market context for product code KPL
FDA has cleared devices under product code KPL between 1977 and 2022, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2022
- 2018
- 2016
- 2015
- 2014
- 2010
- 2007
- 2005
- 2004
- 2002
- 2001
- 2000
- 1998
- 1997
- 1996
Top applicants under product code KPL
Recent clearances under product code KPL
- K201861 — Bio Fluff System
- K180800 — Colonic Plus Regular, Small, and Straight Shape Hydrokit
- K152834 — Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
- K150381 — AQUA CLEANSE
- K131852 — HC-1 AND HC-1 CLASSIC
- K094022 — THE WATER LILY
- K071057 — COLONIC & ENEMA NOZZLE
- K051344 — COLONIC AND ENEMA NOZZLE
- K050992 — CONMED IRRIGATION NOZZLE
- K050112 — PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
- K033149 — ULTIMATE PROFESSIONAL CONTINUOUS FLOW COLONIC SYSTEM
- K003720 — ANGEL OF WATER COLON HYDROTHERAPY SYSTEM
- K002102 — GENTLE COLONICS IRRIGATION SYSTEM
- K000031 — AQUANET, MODEL EC 2000
- K000388 — CLEARWATER COLON HYDROTHERAPY (DISPOSABLE SPECULUM SPO1 LARGE & SP02 SMALL)
- K980868 — GC IRRIGATOR
- K970482 — TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
- K973256 — JIMMY JOHN III RECTAL NOZZLE
- K972455 — JIMMY JOHN III RECTAL NOZZEL, MODEL CIT
- K962259 — LIBBE RECTAL TUBE (FORMERLY A YANKAUER SUCTION TUBE)
- K942867 — CLEARWATER COLON HYDROTHERAPY MODEL PPC-101
- K941279 — LOWER BOWEL EVACUATION SYSTEM
- K902993 — SYSTEMS FLOW 2000
- K894209 — ENEMA KIT
- K891585 — HYDRO-SAN COLONIC IRRIGATION SYSTEM
- K893531 — CUFF SPECULUM
- K885092 — BARIUM ENEMA TUBES: NO. 3001000, 3001001, 3001002
- K881720 — JIMMY JOHN III
- K873948 — MODIFIED RECTAL NOZZLE
- K870534 — DOTOLO COLON HYDROTHERAPY INSTRUMENT
- K870127 — MODIFIED JIMMY JOHN III
- K870376 — JIMMY JOHN III, COLONIC IRRIGATION SYSTEM
- K863539 — HYDRO-CLENZ UNIT
- K860943 — JIMMY JOHN III, RECTAL NOZZLE (MODIFICATION)
- K842083 — JIMMY JOHN III
- K840613 — COLON IRRIGATION UNIT
- K803105 — SARNS INFANT ARTERIAL BUBBLE SENSOR
- K800565 — HESSLER COLON THERAPY DEVICE
- K781923 — NON-RETENTION ENEMA SYSTEM
- K770966 — INTERNAL ECOLOGY MACHINE
Data sourced from openFDA. This site is unofficial and independent of the FDA.