Cleared Traditional

K800305 - WATER CONDUCTIVITY MONITOR & CONTROLLER

K800305 is the FDA 510(k) clearance for WATER CONDUCTIVITY MONITOR & CONTROLLER by Darco Water Systems, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FIP) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K800305 · Darco Water Systems, Inc. · Gastroenterology & Urology device
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Apr 1980
Decision
67d
Days
Class 2
Risk

K800305 is an FDA 510(k) clearance for the WATER CONDUCTIVITY MONITOR & CONTROLLER. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Darco Water Systems, Inc. (Walker, US). The FDA issued a Cleared decision on April 8, 1980 after a review of 67 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 Darco Water Systems, Inc. devices

Submission Details

510(k) Number K800305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1980
Decision Date April 08, 1980
Days to Decision 67 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 130d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 25
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K800305.
HEMO-RO WATER PURIFICATION SYS
K841403 · Millipore Corp. · Jul 1984
EXTRAPURE REVERSE OSMOSIS WATER UNIT
K822385 · Extracorporeal Medical Specialities, Inc. · Oct 1982
GAMBRO WATER PURIFICATION MONITOR WRD
K811678 · Gambro, Inc. · Jul 1981
CENTRY 2 SYSTEM #016, 103, 016, 104
K791086 · Cobe Laboratories, Inc. · Jul 1979
HEMO-RO
K771763 · Millipore Corp. · Oct 1977