Cleared Traditional

K834461 - INFUSION PUMP PRIMER

K834461 is the FDA 510(k) clearance for INFUSION PUMP PRIMER by Parker Hannifin Corp.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K834461 · Parker Hannifin Corp. · General Hospital
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Jan 1984
Decision
42d
Days
Class 2
Risk

K834461 is an FDA 510(k) clearance for the INFUSION PUMP PRIMER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Parker Hannifin Corp. (Walker, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 42 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 Parker Hannifin Corp. devices

Submission Details

510(k) Number K834461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1983
Decision Date January 30, 1984
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 427
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K834461.
ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232
K841922 · American Edwards Laboratories · Jul 1984
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K841784 · Abbott Laboratories · Jun 1984
LIFECARE 4/HOMECARE - 4H PUMP
K840263 · Abbott Laboratories · Feb 1984
GILLETTE SABRE SYRINGE
K833655 · Intermedics, Inc. · Dec 1983
FLO-GARD 8100 INFUSION PUMP
K833958 · Travenol Laboratories, S.A. · Dec 1983
VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY
K832285 · Travenol Laboratories, S.A. · Dec 1983