Cleared Traditional

K060942 - WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

K060942 is an FDA 510(k) clearance for WATER PURIFICATION COMPONENTS FOR HEMOD..., manufactured by Bob J. Johnson & Associates. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K060942 · Bob J. Johnson & Associates · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
92d
Days
Class 2
Risk

K060942 is an FDA 510(k) clearance for the WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Bob J. Johnson & Associates (Houston, US). The FDA issued a Cleared decision on July 7, 2006 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5665 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bob J. Johnson & Associates devices

FDA 510(k) Submission Details - K060942

510(k) Number K060942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2006
Decision Date July 07, 2006
Days to Decision 92 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 131d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIP Device Classification - Class 2, Special Controls

Product Code FIP Subsystem, Water Purification
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5665
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FIP Subsystem, Water Purification

All 82
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K060942.
AQUA PURE DEIONIZER EXCHANGE SERVICE
K072158 · Staubach Barror Water Systems, Inc. · Feb 2008
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
K071104 · Flier'S Quality Water Systems, Inc. · Jan 2008
GAMBRO POSICLEAR
K061782 · Gambro Services, Inc. · Jan 2007
MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
K051620 · Better Water, Inc. · Nov 2005
ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM
K042018 · Simply Clean Air & Water, Inc. · Apr 2005
DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM
K043344 · Dialysis Services, Inc. · Mar 2005