Cleared Traditional

K813446 - IV FILTERSET 0.22 MICROMETER

K813446 is the FDA 510(k) clearance for IV FILTERSET 0.22 MICROMETER by Imed Corp.. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K813446 · Imed Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1982
Decision
27d
Days
Class 2
Risk

K813446 is an FDA 510(k) clearance for the IV FILTERSET 0.22 MICROMETER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Imed Corp. (Walker, US). The FDA issued a Cleared decision on January 5, 1982 after a review of 27 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 Imed Corp. devices

Submission Details

510(k) Number K813446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1981
Decision Date January 05, 1982
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 28
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K813446.
IVEX-INT
K833684 · Abbott Laboratories · Dec 1983
CONTINU-FLO SOLUTION ADMINISTRATION
K831668 · Travenol Laboratories, S.A. · Aug 1983
IVEX-HP PEDIATRIC EXTENSION SET-SL
K821013 · Abbott Laboratories · Jul 1982
TERFUSION FINAL FILTER SET
K810113 · Terumo Medical Corp. · Mar 1981
MODEL 40-30-2 AIR ELIMINATING FILTER SET
K801614 · Y · Aug 1980
B-D FILTER NEEDLE
K801343 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980