Cleared Traditional

K834376 - FILTRARE TM ALLVENT TM

K834376 is an FDA 510(k) clearance for FILTRARE TM ALLVENT TM, manufactured by Alltek, Inc.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K834376 · Alltek, Inc. · General Hospital
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May 1984
Decision
149d
Days
Class 2
Risk

K834376 is an FDA 510(k) clearance for the FILTRARE TM ALLVENT TM. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Alltek, Inc. (Walker, US). The FDA issued a Cleared decision on May 11, 1984 after a review of 149 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Alltek, Inc. devices

FDA 510(k) Submission Details - K834376

510(k) Number K834376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date May 11, 1984
Days to Decision 149 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
20d slower than avg
Panel avg: 129d · This submission: 149d
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 73
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K834376.
POSIDYNE SOLUTION CONTAINER FILTER, RECORDER #96
K850826 · Pall Biomedical Products Co. · Apr 1985
48 HOUR SET CHANGES
K842399 · Tri-Med, Inc. · Oct 1984
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
IVEX-INT
K833684 · Abbott Laboratories · Dec 1983