Cleared Traditional

K863683 - BARD HARVARD(TM) PCA JR INTERMITTENT IN...

K863683 is the FDA 510(k) clearance for BARD HARVARD(TM) PCA JR INTERMITTENT IN... by C.R. Bard, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K863683 · C.R. Bard, Inc. · General Hospital
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Oct 1986
Decision
18d
Days
Class 2
Risk

K863683 is an FDA 510(k) clearance for the BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Murray Hill, US). The FDA issued a Cleared decision on October 7, 1986 after a review of 18 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K863683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1986
Decision Date October 07, 1986
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K863683.
MINIMED MODEL 404-S EXTERNAL INFUSION PUMP
K864138 · Medtronic Minimed · Dec 1986
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K863997 · Abbott Laboratories · Dec 1986
MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS
K864517 · Medtronic Minimed · Dec 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