Cleared Traditional

K842075 - CRITIKON I.V. FILTER

K842075 is an FDA 510(k) clearance for CRITIKON I.V. FILTER, manufactured by Critikon Company, LLC. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K842075 · Critikon Company, LLC · General Hospital
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Jun 1984
Decision
36d
Days
Class 2
Risk

K842075 is an FDA 510(k) clearance for the CRITIKON I.V. FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Critikon Company, LLC (Mchenry, US). The FDA issued a Cleared decision on June 28, 1984 after a review of 36 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K842075

510(k) Number K842075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1984
Decision Date June 28, 1984
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 66
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K842075.
AEF POSIDYNE I.V. FILTER/AIR ELIMINATOR
K850825 · Pall Biomedical Products Co. · Apr 1985
POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96
K850826 · Pall Biomedical Products Co. · Apr 1985
48 HOUR SET CHANGES
K842399 · Tri-Med, Inc. · Oct 1984
POSIDYNE I.V. FILTER/AIR ELIMINATOR
K834381 · Pall Biomedical Products Co. · Apr 1984
IV-FILTER
K840248 · Tri-Med, Inc. · Apr 1984
IVEX-INT
K833684 · Abbott Laboratories · Dec 1983