Cleared Traditional

K982640 - MEDEX 3000 SERIES SYRINGE INFUSION PUMP

K982640 is an FDA 510(k) clearance for MEDEX 3000 SERIES SYRINGE INFUSION PUMP, 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 251-day FDA review.

K982640 · Medex, Inc. · General Hospital
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Apr 1999
Decision
251d
Days
Class 2
Risk

K982640 is an FDA 510(k) clearance for the MEDEX 3000 SERIES SYRINGE INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medex, Inc. (Hilliard, US). The FDA issued a Cleared decision on April 6, 1999 after a review of 251 days - an extended review cycle.

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 - K982640

510(k) Number K982640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 29, 1998
Decision Date April 06, 1999
Days to Decision 251 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 129d · This submission: 251d
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 K982640.
ACCLAIM INFUSION PUMP
K991501 · Abbott Laboratories · May 1999
1000 PRESSURE INFUSION SIGMACON 1000
K990447 · Valley West, Inc. · May 1999
SIDEKICK INFUSION KIT
K990425 · I-Flow Corp. · Apr 1999
PEREGRINE WET SET, MODEL PD400.00
K990518 · Peregrine Surgical , Ltd. · Mar 1999
PAIN CONTROL INFUSION PUMP
K990101 · Sgarlato Laboratories, Inc. · Mar 1999
SABRATEK 4040 INFUSION PUMP
K980751 · Sabratek Corp. · Feb 1999