Cleared Traditional

K915258 - SERVICE DEIONIZATION SYST/DI TANK EXCHA...

K915258 is an FDA 510(k) clearance for SERVICE DEIONIZATION SYST/DI TANK EXCHA..., manufactured by Aqua-Med Systems, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 591-day FDA review.

K915258 · Aqua-Med Systems, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
591d
Days
Class 2
Risk

K915258 is an FDA 510(k) clearance for the SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Aqua-Med Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 591 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 Aqua-Med Systems, Inc. devices

FDA 510(k) Submission Details - K915258

510(k) Number K915258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1991
Decision Date July 02, 1993
Days to Decision 591 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
461d slower than avg
Panel avg: 130d · This submission: 591d
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 K915258.
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