Cleared Traditional

K931595 - REVERSE OSMOSIS EQUIPMENT FOR WATER PUR...

K931595 is an FDA 510(k) clearance for REVERSE OSMOSIS EQUIPMENT FOR WATER PUR..., manufactured by Osmonics, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 638-day FDA review.

K931595 · Osmonics, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1994
Decision
638d
Days
Class 2
Risk

K931595 is an FDA 510(k) clearance for the REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Osmonics, Inc. (Minnetonka, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 638 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 Osmonics, Inc. devices

FDA 510(k) Submission Details - K931595

510(k) Number K931595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1993
Decision Date December 29, 1994
Days to Decision 638 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
508d slower than avg
Panel avg: 130d · This submission: 638d
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 26
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K931595.
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