Cleared Traditional

K000249 - SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100

K000249 is an FDA 510(k) clearance for SCHAEFER WATER CENTER HEMODIALYSIS WATE..., manufactured by Schaefer Water Centers. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K000249 · Schaefer Water Centers · Gastroenterology & Urology device
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Dec 2000
Decision
319d
Days
Class 2
Risk

K000249 is an FDA 510(k) clearance for the SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-100. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Schaefer Water Centers (Herculaneum, US). The FDA issued a Cleared decision on December 11, 2000 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Schaefer Water Centers devices

FDA 510(k) Submission Details - K000249

510(k) Number K000249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2000
Decision Date December 11, 2000
Days to Decision 319 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
188d slower than avg
Panel avg: 131d · This submission: 319d
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 K000249.
WATER PURIFICATION SYSTEM
K994292 · Water & Power Technologies, Inc. · Jan 2001
PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
K994279 · Pure Water Solutions, Inc. · Dec 2000
AIW WATER SYSTEM FOR HEMODIALYSIS
K001282 · American Industrial Water · Dec 2000
NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM
K001811 · Neu-Ion, Inc. · Oct 2000
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