Cleared Traditional

FAST FLOW XX (AQUEOUS SOLUTION FILTER) (K860372) - FDA 510(k) Clearance

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

K860372 · Healthtek, Inc. · General Hospital
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May 1986
Decision
116d
Days
Class 2
Risk

K860372 is an FDA 510(k) clearance for the FAST FLOW XX (AQUEOUS SOLUTION FILTER). Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Healthtek, Inc. (Nevada City, US). The FDA issued a Cleared decision on May 30, 1986 after a review of 116 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 Healthtek, Inc. devices

Submission Details

510(k) Number K860372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1986
Decision Date May 30, 1986
Days to Decision 116 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: 129d · This submission: 116d
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 26
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K860372.
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
K880605 · Miles Laboratories, Inc. · May 1988
CUTTER PUREFLO PLUS IV FILTER
K872634 · Miles Laboratories, Inc. · Aug 1987
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K865029 · Travenol Laboratories, S.A. · Apr 1987
AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
K860746 · Travenol Laboratories, S.A. · Apr 1986
IVEX-INT
K833684 · Abbott Laboratories · Dec 1983
CONTINU-FLO SOLUTION ADMINISTRATION
K831668 · Travenol Laboratories, S.A. · Aug 1983