Cleared Traditional

K121022 - AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV

K121022 is an FDA 510(k) clearance for AMERIWATER ALARM PANEL - BASE MODEL AND..., manufactured by Ameriwater. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K121022 · Ameriwater · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
166d
Days
Class 2
Risk

K121022 is an FDA 510(k) clearance for the AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH COND.... Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Ameriwater (Dayton, US). The FDA issued a Cleared decision on September 17, 2012 after a review of 166 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 Ameriwater devices

FDA 510(k) Submission Details - K121022

510(k) Number K121022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2012
Decision Date September 17, 2012
Days to Decision 166 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
35d slower than avg
Panel avg: 131d · This submission: 166d
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 K121022.
MROZ REVERSE OSMOSIS SYSTEM
K131622 · Ameriwater · Sep 2013
DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
K123282 · Ultrapure & Industrial Services, LLC · Apr 2013
AQUABOSS ECORO DIA I (HT)
K124059 · Lauer Membran Wassertechnik GmbH · Mar 2013
BIOPURE PORTABLE RO SYSTEMS
K112331 · Arion Water, Inc. · Jul 2012
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
K111740 · Ameriwater · Oct 2011
NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER
K110285 · Nephros, Inc. · Jul 2011