Cleared Traditional

K834447 - ECHO MM1000

K834447 is the FDA 510(k) clearance for ECHO MM1000 by Mesa Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code LIF) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K834447 · Mesa Medical, Inc. · Gastroenterology & Urology device
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Mar 1984
Decision
98d
Days
Class 2
Risk

K834447 is an FDA 510(k) clearance for the ECHO MM1000. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Mesa Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Mesa Medical, Inc. devices

Submission Details

510(k) Number K834447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1983
Decision Date March 23, 1984
Days to Decision 98 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 130d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIF Dialyzer Reprocessing System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - LIF Dialyzer Reprocessing System

All 12
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K834447.
RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330
K904210 · Minntech Corp. · Nov 1990
COBE REN NEW-D DISPENSING KIT
K853817 · Cobe Laboratories, Inc. · Oct 1985
RENATRON
K842258 · Renal Systems, Inc. · Jul 1984
HPR HOME PATIENT RENATRON
K833181 · Renal Systems, Inc. · Oct 1983
RENALIN (TENTATIVE
K830575 · Renal Systems, Inc. · Mar 1983
RENATRON DIALYZER REPROCESSING SYS
K830574 · Renal Systems, Inc. · Mar 1983