Cleared Traditional

K842399 - 48 HOUR SET CHANGES

K842399 is the FDA 510(k) clearance for 48 HOUR SET CHANGES 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.

K842399 · Tri-Med, Inc. · General Hospital
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Oct 1984
Decision
112d
Days
Class 2
Risk

K842399 is an FDA 510(k) clearance for the 48 HOUR SET CHANGES. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Tri-Med, Inc. (Huntington Beach, US). The FDA issued a Cleared decision on October 9, 1984 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 K842399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1984
Decision Date October 09, 1984
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 K842399.
PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE
K855065 · Cobe Laboratories, Inc. · Feb 1986
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
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