Cleared Traditional

K992793 - SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM

K992793 is an FDA 510(k) clearance for SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, manufactured by Better Water, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIN cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K992793 · Better Water, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
89d
Days
Class 2
Risk

K992793 is an FDA 510(k) clearance for the SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM. Classified as Tank, Holding, Dialysis (product code FIN), Class II - Special Controls.

Submitted by Better Water, Inc. (Smyrna, US). The FDA issued a Cleared decision on November 16, 1999 after a review of 89 days - a notably fast clearance cycle.

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: 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 Better Water, Inc. devices

FDA 510(k) Submission Details - K992793

510(k) Number K992793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1999
Decision Date November 16, 1999
Days to Decision 89 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
42d faster than avg
Panel avg: 131d · This submission: 89d
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 K992793.
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
K051031 · Ameriwater · Jan 2006
PURE WATER, INC.'S BICARB MIX, STORAGE AND DISTRIBUTION SYSTEM
K993272 · Pure Water, Inc. · Apr 2000
PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL
K993058 · Pure Water, Inc. · Jan 2000
G.E.M. WATER SYSTEMS, INTERNATIONAL
K970674 · G.E.M. Water Systems · Nov 1997
DIALYSIS MIXING & HOLDING TANK
K961416 · Dial Medical Supply · Aug 1996
NATURALYTE MIXER
K883408 · National Medical Care, Medical Products Div., Inc. · Oct 1988