Cleared Traditional

K993200 - MD 420/440/460/470/480/490

K993200 is the FDA 510(k) clearance for MD 420/440/460/470/480/490 by Isopure, Corp.. It is a Class 2 Gastroenterology & Urology device (product code FIP) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K993200 · Isopure, Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
122d
Days
Class 2
Risk

K993200 is an FDA 510(k) clearance for the MD 420/440/460/470/480/490. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Isopure, Corp. (Louisville, US). The FDA issued a Cleared decision on January 24, 2000 after a review of 122 days - within the typical 510(k) review window.

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 Isopure, Corp. devices

Submission Details

510(k) Number K993200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1999
Decision Date January 24, 2000
Days to Decision 122 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 130d · This submission: 122d
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 20
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K993200.
DIASAFEplusUS
K182367 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2019
EON Portable Reverse Osmosis Water Purification System
K171099 · Cantel · Jan 2018
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · Fresenius USA, Inc. · Nov 1995
ASCORBIC ACID
K842215 · Organon Teknika Corp. · Aug 1984
EXTRAPURE REVERSE OSMOSIS WATER UNIT
K822385 · Extracorporeal Medical Specialities, Inc. · Oct 1982