Cleared Traditional

K842027 - IVAC 3080 ENTERAL FEEDING PUMP

K842027 is the FDA 510(k) clearance for IVAC 3080 ENTERAL FEEDING PUMP by Y. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K842027 · Y · General Hospital

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Jul 1984

Decision

61d

Days

Class 2

Risk

K842027 is an FDA 510(k) clearance for the IVAC 3080 ENTERAL FEEDING PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Y (Walker, US). The FDA issued a Cleared decision on July 18, 1984 after a review of 61 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 Y devices

Submission Details

510(k) Number	K842027 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 18, 1984
Decision Date	July 18, 1984
Days to Decision	61 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

68d faster than avg

Panel avg: 129d · This submission: 61d

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 447

Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K842027.

ENTERAL FEEDING PUMP 14-800 SERIES

K843168 · Biosearch Medical Products, Inc. · Oct 1984

MODULAR VOLUMETRIC INFUSION PUMP SYS

K843274 · American Edwards Laboratories · Oct 1984

ARGYLE ENTERITE ENTERAL FEEDING PUMP

K842421 · Sherwood Medical Co. · Aug 1984

ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232

K841922 · American Edwards Laboratories · Jul 1984

FLEXIFLO-III PORTABLE ENTERAL NUTRI

K841784 · Abbott Laboratories · Jun 1984

LIFECARE 4/HOMECARE - 4H PUMP

K840263 · Abbott Laboratories · Feb 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K842027

Walker, MI · US

Regulatory profile

78 submissions 78 cleared

100% clearance rate · Active in General Hospital

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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