Cleared Traditional

K802765 - ACRODISC FILTER ASSEMBLY

K802765 is the FDA 510(k) clearance for ACRODISC FILTER ASSEMBLY by Gelman Sciences, Inc.. It is a Class 2 Chemistry device (product code FPB) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K802765 · Gelman Sciences, Inc. · Chemistry device
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Jan 1981
Decision
78d
Days
Class 2
Risk

K802765 is an FDA 510(k) clearance for the ACRODISC FILTER ASSEMBLY. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1981 after a review of 78 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 Gelman Sciences, Inc. devices

Submission Details

510(k) Number K802765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1980
Decision Date January 21, 1981
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 88d · This submission: 78d
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 42
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K802765.
IV FILTERSET 5 MICROMETER
K813445 · Imed Corp. · Jan 1982
IV FILTERSET 0.22 MICROMETER
K813446 · Imed Corp. · Jan 1982
TERFUSION FINAL FILTER SET
K810113 · Terumo Medical Corp. · Mar 1981
MODEL 40-30-2 AIR ELIMINATING FILTER SET
K801614 · Y · Aug 1980
BIMECO FILTERED EXTENSION SET
K801605 · Burron Medical Products, Inc. · Aug 1980
B-D FILTER NEEDLE
K801343 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980