Cleared Traditional

K983126 - FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS

K983126 is an FDA 510(k) clearance for FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS, manufactured by Minntech Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K983126 · Minntech Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
181d
Days
Class 2
Risk

K983126 is an FDA 510(k) clearance for the FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on March 8, 1999 after a review of 181 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 Minntech Corp. devices

FDA 510(k) Submission Details - K983126

510(k) Number K983126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1998
Decision Date March 08, 1999
Days to Decision 181 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
50d slower than avg
Panel avg: 131d · This submission: 181d
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 48
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K983126.
VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K991916 · Virginia Water Systems, Inc. · Jan 2000
WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS
K983239 · Rasco · Nov 1999
WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K983512 · Water Vault, Inc. · Apr 1999
ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS
K981680 · Dayton Water Systems · Dec 1998
WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K980182 · Usfilter/Ionpure, Inc. · Nov 1998
GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H
K974899 · Gambro Healthcare · Sep 1998