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
Download Printable Device Report (PDF)
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
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 130d · 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 Peers - FIP Subsystem, Water Purification

All 26
Devices cleared under the same product code (FIP) and FDA review panel - the closest regulatory comparables to K032004.
DIASAFEplusUS
K182367 · Fresenius Medical Care Renal Therapies Group, LLC · Jan 2019
EON Portable Reverse Osmosis Water Purification System
K171099 · Cantel · Jan 2018
NX STAGE WATER PURIFICATION SYSTEM
K042089 · Nxstage Medical, Inc. · Nov 2004
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
K983126 · Minntech Corp. · Mar 1999
FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS
K954349 · Minntech Corp. · Dec 1995
DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER
K944767 · Fresenius USA, Inc. · Nov 1995