Cleared Traditional

K813446 - IV FILTERSET 0.22 MICROMETER

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

K813446 · Imed Corp. · General Hospital
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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

FDA 510(k) Submission Details - K813446

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
Combination Product No
PCCP Authorized No
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.

FPB Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K813446.
IVFLO-HP & IVFIL-HP
K823690 · Tri-Med, Inc. · Dec 1982
IVEX-HP PEDIATRIC EXTENSION SET-SL
K821013 · Abbott Laboratories · Jul 1982
IV FILTERSET 5 MICROMETER
K813445 · Imed Corp. · Jan 1982
FIBRI-FILTER 20
K813001 · Tri-Med, Inc. · Nov 1981
HIFLO-HP
K812457 · Tri-Med, Inc. · Sep 1981
BACTAGARD
K811773 · Tri-Med, Inc. · Jul 1981