Cleared Traditional

K894106 - DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST

K894106 is an FDA 510(k) clearance for DRAKE WILLOCK REVERSE OSMOSIS WATER TRE..., manufactured by Cd Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K894106 · Cd Medical, Inc. · Gastroenterology & Urology device
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Nov 1989
Decision
152d
Days
Class 2
Risk

K894106 is an FDA 510(k) clearance for the DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Cd Medical, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on November 8, 1989 after a review of 152 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 Cd Medical, Inc. devices

FDA 510(k) Submission Details - K894106

510(k) Number K894106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1989
Decision Date November 08, 1989
Days to Decision 152 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
21d slower than avg
Panel avg: 131d · This submission: 152d
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 80
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K894106.
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · Fresenius USA, Inc. · Nov 1995
SERIM HISENSE TEST KIT
K952215 · Serim Research Corp. · Aug 1995
RENAGUARD DIALYSATE FILTER
K945136 · Minntech Corp. · Feb 1995
ASCORBIC ACID
K842215 · Organon Teknika Corp. · Aug 1984
HEMO-RO WATER PURIFICATION SYS
K841403 · Millipore Corp. · Jul 1984
EXTRAPURE REVERSE OSMOSIS WATER UNIT
K822385 · Extracorporeal Medical Specialities, Inc. · Oct 1982