Cleared Traditional

K993058 - PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL

K993058 is an FDA 510(k) clearance for PURE WATER INC'S ACIDIFIED STORAGE AND ..., manufactured by Pure Water, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIN cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K993058 · Pure Water, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
133d
Days
Class 2
Risk

K993058 is an FDA 510(k) clearance for the PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMO.... Classified as Tank, Holding, Dialysis (product code FIN), Class II - Special Controls.

Submitted by Pure Water, Inc. (Anderson, US). The FDA issued a Cleared decision on January 24, 2000 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Pure Water, Inc. devices

FDA 510(k) Submission Details - K993058

510(k) Number K993058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1999
Decision Date January 24, 2000
Days to Decision 133 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
2d slower than avg
Panel avg: 131d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIN Device Classification - Class 2, Special Controls

Product Code FIN Tank, Holding, Dialysis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FIN Tank, Holding, Dialysis

All 11
Devices cleared under the same product code (FIN) and FDA review panel - the closest regulatory comparables to K993058.
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PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
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SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
K992793 · Better Water, Inc. · Nov 1999
G.E.M. WATER SYSTEMS, INTERNATIONAL
K970674 · G.E.M. Water Systems · Nov 1997
DIALYSIS MIXING & HOLDING TANK
K961416 · Dial Medical Supply · Aug 1996