Cleared Traditional

K790108 - FILTERSET 0.22

K790108 is the FDA 510(k) clearance for FILTERSET 0.22 by Imed Corp.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K790108 · Imed Corp. · General Hospital
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Mar 1979
Decision
49d
Days
Class 2
Risk

K790108 is an FDA 510(k) clearance for the FILTERSET 0.22, I.V. PUMP. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Imed Corp. (Mchenry, US). The FDA issued a Cleared decision on March 6, 1979 after a review of 49 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 K790108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1979
Decision Date March 06, 1979
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 281
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K790108.
CONTINU-FLO ADMIN. SET CODE 2C/200
K792538 · Travenol Laboratories, S.A. · Dec 1979
IV EXTENSION SET SL
K791930 · Abbott Laboratories · Oct 1979
INTRAVASCULAR ADMINISTRATION SET
K790582 · Y · May 1979
SOLUTION ADMINISTRATION, TIP PROTECTOR
K781813 · Travenol Laboratories, S.A. · Jan 1979
FILTER FOR HYPERALIMENTATION SET
K782134 · Travenol Laboratories, S.A. · Jan 1979
MODEL IV 1500 STANDARD BURETTE
K781637 · Valleylab, Inc. · Dec 1978