Cleared Traditional

K861436 - SOF SET

K861436 is the FDA 510(k) clearance for SOF SET by Pacesetter Systems. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K861436 · Pacesetter Systems · General Hospital
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Jun 1986
Decision
53d
Days
Class 2
Risk

K861436 is an FDA 510(k) clearance for the SOF SET, MODELS 111 AND 112. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on June 9, 1986 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pacesetter Systems devices

Submission Details

510(k) Number K861436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1986
Decision Date June 09, 1986
Days to Decision 53 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
76d faster than avg
Panel avg: 129d · This submission: 53d
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 443
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K861436.
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 113 AND 114
K860857 · Pacesetter Systems · May 1986
BECTON DICKINSON PCAINFUSER
K861007 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1986
IV7200 AND IV7400 INFUSION PUMP
K860694 · Valleylab, Inc. · Apr 1986