Cleared Traditional

K993520 - H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K993520 is an FDA 510(k) clearance for H20NLY COMPLETE WATER PURIFICATION SYST..., manufactured by Serv-A-Pure Co.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K993520 · Serv-A-Pure Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
198d
Days
Class 2
Risk

K993520 is an FDA 510(k) clearance for the H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Serv-A-Pure Co. (Bay City, US). The FDA issued a Cleared decision on May 3, 2000 after a review of 198 days - an extended review 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: 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 Serv-A-Pure Co. devices

FDA 510(k) Submission Details - K993520

510(k) Number K993520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1999
Decision Date May 03, 2000
Days to Decision 198 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
67d slower than avg
Panel avg: 131d · This submission: 198d
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 K993520.
FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS
K991495 · Fluid Process Systems, Inc. · Aug 2000
DIALGUARD ENDOTOXIN REMOVAL DEVICE
K993806 · Clarigen, Inc. · Aug 2000
NELSON WATER SYSTEMS FOR HEMODIALYSIS
K993877 · Nelson Environmental Technologies, Inc. · May 2000
AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991519 · Ameriwater · Apr 2000
PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
K992786 · Pure Water, Inc. · Jan 2000
MD 420/440/460/470/480/490
K993200 · Isopure, Corp. · Jan 2000