Cleared Traditional

K983239 - WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS

K983239 is an FDA 510(k) clearance for WATER PURIFICATION COMPONENTS AND SYSTE..., manufactured by Rasco. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 429-day FDA review.

K983239 · Rasco · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
429d
Days
Class 2
Risk

K983239 is an FDA 510(k) clearance for the WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Rasco (Woodbridge, US). The FDA issued a Cleared decision on November 18, 1999 after a review of 429 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Rasco devices

FDA 510(k) Submission Details - K983239

510(k) Number K983239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1998
Decision Date November 18, 1999
Days to Decision 429 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
298d slower than avg
Panel avg: 131d · This submission: 429d
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 82
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K983239.
PURE WATER, INC.'S WATER PURIFICATION SYSTEMS
K992786 · Pure Water, Inc. · Jan 2000
MD 420/440/460/470/480/490
K993200 · Isopure, Corp. · Jan 2000
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991916 · Virginia Water Systems, Inc. · Jan 2000
WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K983512 · Water Vault, Inc. · Apr 1999
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
K983126 · Minntech Corp. · Mar 1999
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K981680 · Dayton Water Systems · Dec 1998