Cleared Traditional

K980165 - INFUTEST 2000 INFUSION DEVICE ANALYZER

K980165 is an FDA 510(k) clearance for INFUTEST 2000 INFUSION DEVICE ANALYZER, manufactured by Datrend Systems, Inc.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K980165 · Datrend Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
94d
Days
Class 2
Risk

K980165 is an FDA 510(k) clearance for the INFUTEST 2000 INFUSION DEVICE ANALYZER. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Datrend Systems, Inc. (Burnaby, British Columbia, CA). The FDA issued a Cleared decision on April 20, 1998 after a review of 94 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Datrend Systems, Inc. devices

FDA 510(k) Submission Details - K980165

510(k) Number K980165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1998
Decision Date April 20, 1998
Days to Decision 94 days
Submission Type Traditional
Review Panel General Hospital (HO)
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 faster than avg
Panel avg: 129d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - MRZ Accessories, Pump, Infusion

All 23
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K980165.
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
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K072955 · Smiths Medical MD, Inc. · Feb 2008
S.P.A.R STERILE AMBULATORY RESERVOIR
K990091 · Faulding Pharmaceutical Co. · Apr 1999
THE HARVARD LIBRARY
K970678 · Harvard Apparatus, Inc. · Jan 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS3030-P
K972779 · Alexander Mfg. Co. · Oct 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625
K972780 · Alexander Mfg. Co. · Oct 1997