Cleared Traditional

K771826 - INTRAVENOUS FILTER W/AUTO AIR VENT

K771826 is the FDA 510(k) clearance for INTRAVENOUS FILTER W/AUTO AIR VENT by Jelco Laboratories. It is a Class 2 Chemistry device (product code FPB) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K771826 · Jelco Laboratories · Chemistry device
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Oct 1977
Decision
24d
Days
Class 2
Risk

K771826 is an FDA 510(k) clearance for the INTRAVENOUS FILTER W/AUTO AIR VENT. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Jelco Laboratories (Mchenry, US). The FDA issued a Cleared decision on October 13, 1977 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5440 - the FDA in vitro diagnostics and chemistry 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 Jelco Laboratories devices

Submission Details

510(k) Number K771826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1977
Decision Date October 13, 1977
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
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 Chemistry devices follow this clearance model.

Regulatory Peers - FPB Filter, Infusion Line

All 28
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K771826.
BIOGUARD INFUSION LINE FILTER
K791822 · United States Surgical, A Division of Tyco Healthc · Nov 1979
FILTERSET W/Y-INJECTION SITE, 0.2
K772312 · Abbott Laboratories · Jan 1978
5UM FILTERSET WITH Y-INJECTION SITE
K771972 · Abbott Laboratories · Jan 1978
PRIMARY PIGGYBACK VENOSET W/ FILTER
K771594 · Abbott Laboratories · Sep 1977
CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET
K771498 · Travenol Laboratories, S.A. · Aug 1977
IV PUMP FILTERSET, UNIVERSAL
K770843 · Abbott Laboratories · Jun 1977