Cleared Traditional

K014169 - WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

K014169 is an FDA 510(k) clearance for WATER PURIFICATION COMPONENTS FOR HEMOD..., manufactured by Bob J. Johnson & Assoc., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K014169 · Bob J. Johnson & Assoc., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
49d
Days
Class 2
Risk

K014169 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 & Assoc., Inc. (San Antonio,, US). The FDA issued a Cleared decision on February 6, 2002 after a review of 49 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bob J. Johnson & Assoc., Inc. devices

FDA 510(k) Submission Details - K014169

510(k) Number K014169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2001
Decision Date February 06, 2002
Days to Decision 49 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
82d faster than avg
Panel avg: 131d · This submission: 49d
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 99
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K014169.
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
K001755 · Mpw Industrial Water Services, Inc. · Aug 2002
DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
K021352 · Dayton Water Systems · Aug 2002
MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM
K013677 · Usfilter/Ionpure, Inc. · Mar 2002
DIACLEAR ULTRAFILTER
K003957 · Gambro Renal Products · Nov 2001
AQUA WATER TREATMENT FOR HEMODIALYSIS
K010592 · Aqua Water Treatment, Inc. · Sep 2001
MAR COR SERVICES SEMPER PURE RO MACHINE
K003877 · Mar Cor Services, Inc. · Jun 2001