Cleared Traditional

K954349 - FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS

K954349 is an FDA 510(k) clearance for FIBERFLO HOLLOW FIBER CARTRIDGE WATER F..., 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 88-day FDA review.

K954349 · Minntech Corp. · Gastroenterology & Urology device
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Dec 1995
Decision
88d
Days
Class 2
Risk

K954349 is an FDA 510(k) clearance for the FIBERFLO HOLLOW FIBER CARTRIDGE 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 December 15, 1995 after a review of 88 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 Minntech Corp. devices

FDA 510(k) Submission Details - K954349

510(k) Number K954349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1995
Decision Date December 15, 1995
Days to Decision 88 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
43d faster than avg
Panel avg: 131d · This submission: 88d
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 K954349.
MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS
K945559 · Mar Cor Services, Inc. · May 1996
REVERSE OSMOSIS SYSTEM
K944493 · G.E.M. Water Systems · Feb 1996
PORTABLE REVERSE OSMOSIS MACHINE
K954928 · Better Water, Inc. · Jan 1996
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