Cleared Traditional

K844401 - REPRO-MED SYSTEMS INFUSION DEVICE

K844401 is an FDA 510(k) clearance for REPRO-MED SYSTEMS INFUSION DEVICE, manufactured by Repro-Med Systems, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K844401 · Repro-Med Systems, Inc. · General Hospital
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Mar 1985
Decision
119d
Days
Class 2
Risk

K844401 is an FDA 510(k) clearance for the REPRO-MED SYSTEMS INFUSION DEVICE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Repro-Med Systems, Inc. (Middletown, US). The FDA issued a Cleared decision on March 12, 1985 after a review of 119 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 Repro-Med Systems, Inc. devices

FDA 510(k) Submission Details - K844401

510(k) Number K844401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date March 12, 1985
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
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 527
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K844401.
IMED 440 INFUSION PUMP & ADMINISTRATION SET
K850653 · Imed Corp. · Apr 1985
PROMINJECT PROGRAMMABLE INFUSION PUMP
K850669 · Pharmacia, Inc. · Apr 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP 1030
K850488 · Strato Medical Corp. · Mar 1985
IMED 980 VOLUMETRIC INFUSION PUMP
K844915 · Imed Corp. · Mar 1985
HOME PRO VOLUMETRIC INFUSION PUMP
K841374 · American Edwards Laboratories · Feb 1985
STRATOFUSE SYRINGE PIGGYBACK PUMP
K844627 · Strato Medical Corp. · Jan 1985