Cleared Traditional

NIKKISO INFUSION PUMP MODEL PFA-02 (K861539) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 263
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K861539.
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K863997 · Abbott Laboratories · Dec 1986
BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP
K863683 · C.R. Bard, Inc. · Oct 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