Cleared Traditional

K865029 - CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K865029 · Travenol Laboratories, S.A. · General Hospital
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Apr 1987
Decision
115d
Days
Class 2
Risk

K865029 is an FDA 510(k) clearance for the CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on April 17, 1987 after a review of 115 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K865029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1986
Decision Date April 17, 1987
Days to Decision 115 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
13d faster than avg
Panel avg: 128d · This submission: 115d
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.