Cleared Traditional

K831315 - TRILEX

K831315 is the FDA 510(k) clearance for TRILEX by Tri-Med, Inc.. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K831315 · Tri-Med, Inc. · General Hospital
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Aug 1983
Decision
112d
Days
Class 2
Risk

K831315 is an FDA 510(k) clearance for the TRILEX. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Tri-Med, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 112 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 Tri-Med, Inc. devices

Submission Details

510(k) Number K831315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1983
Decision Date August 12, 1983
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 60
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K831315.
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
IVFLO-HP & IVFIL-HP FILTER
K831350 · Tri-Med, Inc. · Aug 1983
IVFLO-HP & IVFIL-HP
K823690 · Tri-Med, Inc. · Dec 1982
IVEX-HP PEDIATRIC EXTENSION SET-SL
K821013 · Abbott Laboratories · Jul 1982