Cleared Traditional

K791809 - BLOOD TRANSFUSION MICROFILTER

K791809 is the FDA 510(k) clearance for BLOOD TRANSFUSION MICROFILTER by Pioneer Viggo, Inc.. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K791809 · Pioneer Viggo, Inc. · General Hospital
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Oct 1979
Decision
39d
Days
Class 2
Risk

K791809 is an FDA 510(k) clearance for the BLOOD TRANSFUSION MICROFILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Pioneer Viggo, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 26, 1979 after a review of 39 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Pioneer Viggo, Inc. devices

Submission Details

510(k) Number K791809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1979
Decision Date October 26, 1979
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPB Filter, Infusion Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPB Filter, Infusion Line

All 54
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K791809.
B-D FILTER NEEDLE
K801343 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980
MICROBAR MONITORING LINE FILTER
K792510 · Medex, Inc. · Dec 1979
BIOGUARD INFUSION LINE FILTER
K791822 · United States Surgical, A Division of Tyco Healthc · Nov 1979
LARGE VOLUME 5 MICRON CONICAL FILTER
K792021 · National Patent Development Corp. · Oct 1979
FLUID ADMINISTRATION SETS, 15 MICRON
K790314 · Medex, Inc. · Mar 1979
FILTERSET W/Y-INJECTION SITE, 0.2
K772312 · Abbott Laboratories · Jan 1978