Cleared Traditional

K833684 - IVEX-INT

K833684 is an FDA 510(k) clearance for IVEX-INT, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K833684 · Abbott Laboratories · General Hospital
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Dec 1983
Decision
57d
Days
Class 2
Risk

K833684 is an FDA 510(k) clearance for the IVEX-INT. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 57 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K833684

510(k) Number K833684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1983
Decision Date December 27, 1983
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 65
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K833684.
CRITIKON I.V. FILTER
K842075 · Critikon Company, LLC · Jun 1984
POSIDYNE I.V. FILTER/AIR ELIMINATOR
K834381 · Pall Biomedical Products Co. · Apr 1984
IV-FILTER
K840248 · Tri-Med, Inc. · Apr 1984
MILLIPORE IVEX INT FILTER UNIT
K832952 · Millipore Corp. · Oct 1983
POSIDYNE SOLUTION CONTAINER FILTER
K831882 · Pall Biomedical Products Co. · Sep 1983
CONTINU-FLO SOLUTION ADMINISTRATION
K831668 · Travenol Laboratories, S.A. · Aug 1983