Cleared Traditional

K940327 - INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW (FDA 510(k) Clearance)

Class I General Hospital device.

K940327 · W.L. Gore & Associates, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
32d
Days
Class 1
Risk

K940327 is an FDA 510(k) clearance for the INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT .... Classified as Cover, Mattress (medical Purposes) (product code FMW), Class I - General Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6190 - 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K940327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1994
Decision Date February 25, 1994
Days to Decision 32 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 128d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMW Cover, Mattress (medical Purposes)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6190
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.