Cleared Traditional

K861539 - NIKKISO INFUSION PUMP MODEL PFA-02

K861539 is an FDA 510(k) clearance for NIKKISO INFUSION PUMP MODEL PFA-02, manufactured by International Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K861539 · International Medical Products, Inc. · General Hospital
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Jul 1986
Decision
98d
Days
Class 2
Risk

K861539 is an FDA 510(k) clearance for the NIKKISO INFUSION PUMP MODEL PFA-02. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by International Medical Products, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 31, 1986 after a review of 98 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 International Medical Products, Inc. devices

FDA 510(k) Submission Details - K861539

510(k) Number K861539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1986
Decision Date July 31, 1986
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 528
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K861539.
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
K863683 · C.R. Bard, Inc. · Oct 1986
MODEL PC-2 VOLUMETRIC INFUSION PUMP/CONTROLLER
K862295 · Imed Corp. · Sep 1986
SYRINGE INFUSION PUMP
K860353 · Travenol Laboratories, S.A. · Sep 1986
SOF SET, MODELS 111 AND 112
K861436 · Pacesetter Systems · Jun 1986
SOF SET, MODELS 113 AND 114
K860857 · Pacesetter Systems · May 1986
BECTON DICKINSON PCAINFUSER
K861007 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1986