Cleared Traditional

RAPIDEX BIOLOGICAL SURFACTANT (K862282) - FDA 510(k) Clearance

Class I General Hospital device.

K862282 · Rapidex of London · General Hospital
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May 1987
Decision
329d
Days
Class 1
Risk

K862282 is an FDA 510(k) clearance for the RAPIDEX BIOLOGICAL SURFACTANT. Classified as Cleaner, Ultrasonic, Medical Instrument (product code FLG), Class I - General Controls.

Submitted by Rapidex of London (Richmond, Surrey, GB). The FDA issued a Cleared decision on May 11, 1987 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6150 - 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. Elevated predicate reliance profile. 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 Rapidex of London devices

Submission Details

510(k) Number K862282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1986
Decision Date May 11, 1987
Days to Decision 329 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
200d slower than avg
Panel avg: 129d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FLG Cleaner, Ultrasonic, Medical Instrument
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6150
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.