Cleared Traditional

K862282 - RAPIDEX BIOLOGICAL SURFACTANT

K862282 is an FDA 510(k) clearance for RAPIDEX BIOLOGICAL SURFACTANT, manufactured by Rapidex of London. The device is a Class 1 General Hospital device with product code FLG cleared through the Traditional 510(k) pathway after a 329-day FDA review.

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

FDA 510(k) Submission Details - K862282

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.

FLG Device Classification - Class 1, General Controls

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.