Cleared Traditional

K032004 - AQUABOSS ECORO DIA 50

K032004 is an FDA 510(k) clearance for AQUABOSS ECORO DIA 50, manufactured by Lauer Ltd., Hong Kong. The device is a Class 2 Gastroenterology & Urology device with product code FIP cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K032004 · Lauer Ltd., Hong Kong · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Oct 2003
Decision
94d
Days
Class 2
Risk

K032004 is an FDA 510(k) clearance for the AQUABOSS ECORO DIA 50. Classified as Subsystem, Water Purification (product code FIP), Class II - Special Controls.

Submitted by Lauer Ltd., Hong Kong (Wittlingen, DE). The FDA issued a Cleared decision on October 2, 2003 after a review of 94 days - within the typical 510(k) review window.

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 Lauer Ltd., Hong Kong devices

FDA 510(k) Submission Details - K032004

510(k) Number K032004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2003
Decision Date October 02, 2003
Days to Decision 94 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 131d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FIP Subsystem, Water Purification

All 101
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K032004.
MEGA PURE CART
K031832 · Mega Services · Oct 2004
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
K041163 · Isopure, Corp. · Oct 2004
BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE
K030348 · Biolab Equipment Canada , Ltd. · Oct 2003
MEDRO SPD
K030652 · Usfilter/Ionpure, Inc. · Sep 2003
MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K021560 · Ameriwater · Aug 2003
WATER PURIFICATION SYSTEM
K022448 · Purity Water Company of San Antonio, Inc. · May 2003

FDA 510(k) Resources - Gastroenterology & Urology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.