Cleared Traditional

K823690 - IVFLO-HP & IVFIL-HP

K823690 is the FDA 510(k) clearance for IVFLO-HP & IVFIL-HP by Tri-Med, Inc.. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K823690 · Tri-Med, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
20d
Days
Class 2
Risk

K823690 is an FDA 510(k) clearance for the IVFLO-HP & IVFIL-HP. 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 December 28, 1982 after a review of 20 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 Tri-Med, Inc. devices

Submission Details

510(k) Number K823690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1982
Decision Date December 28, 1982
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 K823690.
CONTINU-FLO SOLUTION ADMINISTRATION
K831668 · Travenol Laboratories, S.A. · Aug 1983
TRILEX
K831315 · Tri-Med, Inc. · Aug 1983
IVFLO-HP & IVFIL-HP FILTER
K831350 · Tri-Med, Inc. · Aug 1983
IVEX-HP PEDIATRIC EXTENSION SET-SL
K821013 · Abbott Laboratories · Jul 1982
IV FILTERSET 5 MICROMETER
K813445 · Imed Corp. · Jan 1982
IV FILTERSET 0.22 MICROMETER
K813446 · Imed Corp. · Jan 1982