Cleared Traditional

K872514 - INFUSION PUMP MODEL 270

K872514 is an FDA 510(k) clearance for INFUSION PUMP MODEL 270, manufactured by Avi, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K872514 · Avi, Inc. · General Hospital
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Dec 1987
Decision
175d
Days
Class 2
Risk

K872514 is an FDA 510(k) clearance for the INFUSION PUMP MODEL 270. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Avi, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 16, 1987 after a review of 175 days - an extended review 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: 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 Avi, Inc. devices

FDA 510(k) Submission Details - K872514

510(k) Number K872514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1987
Decision Date December 16, 1987
Days to Decision 175 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
46d slower than avg
Panel avg: 129d · This submission: 175d
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 618
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K872514.
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
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K873961 · Med Fusion Systems, Inc. · Dec 1987
BARD MICROINFUSER I INSULIN INFUSION PUMP
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IVAC(R) DUAL RATE SET - MODEL C50066
K873938 · Y · Dec 1987
CORMED III AMBULATORY INFUSION PUMP
K873847 · C.R. Bard, Inc. · Dec 1987
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+
K873776 · Y · Dec 1987