Cleared Traditional

K000328 - MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP

K000328 is an FDA 510(k) clearance for MEDEX 3000 SERIES MRI COMPATIBLE SYRING..., manufactured by Medex, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K000328 · Medex, Inc. · General Hospital
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May 2000
Decision
97d
Days
Class 2
Risk

K000328 is an FDA 510(k) clearance for the MEDEX 3000 SERIES MRI COMPATIBLE SYRINGE INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medex, Inc. (Dublin, US). The FDA issued a Cleared decision on May 9, 2000 after a review of 97 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 Medex, Inc. devices

FDA 510(k) Submission Details - K000328

510(k) Number K000328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2000
Decision Date May 09, 2000
Days to Decision 97 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
32d faster than avg
Panel avg: 129d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN 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 - FRN Pump, Infusion

All 587
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K000328.
ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP
K002126 · Abbott Laboratories · Jul 2000
CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM
K000842 · Sims Deltec, Inc. · Jun 2000
QUEST MPS PERFUSION ASSISTED DIRECT CORONARY ARTERY BYPASS (PADCAB)
K994274 · Quest Medical, Inc. · May 2000
ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION
K000821 · Abbott Laboratories · Mar 2000
HORIZON LIGHT
K994375 · B.Braun Medical, Inc. · Mar 2000
SOAKER CATHETER
K994374 · I-Flow Corp. · Mar 2000