Cleared Traditional

K992702 - EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM

K992702 is an FDA 510(k) clearance for EVENT ALLERGEN BARRIERS, manufactured by Allergy Direct. The device is a Class 1 General Hospital device with product code FMW cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K992702 · Allergy Direct · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
88d
Days
Class 1
Risk

K992702 is an FDA 510(k) clearance for the EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT.... Classified as Cover, Mattress (medical Purposes) (product code FMW), Class I - General Controls.

Submitted by Allergy Direct (Kansas City, US). The FDA issued a Cleared decision on November 8, 1999 after a review of 88 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 Allergy Direct devices

FDA 510(k) Submission Details - K992702

510(k) Number K992702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1999
Decision Date November 08, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

FMW Device Classification - Class 1, General Controls

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.

Regulatory Peers - FMW Cover, Mattress (medical Purposes)

Devices cleared under the same product code (FMW) and FDA review panel - the closest regulatory comparables to K992702.
DermaTherapy Bed Linens
K152884 · Precision Fabrics Group, Inc. · Jun 2016
INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW
K940327 · W.L. Gore & Associates, Inc. · Feb 1994
DISPOSABLE STERILE TABLE TOP COVER FOR HYDRADJUST
K902446 · Mallinckrodt Group, Inc. · Aug 1990
MATTRESS COVER, ANTI-MICROBIAL
K832483 · American Threshold Industries, Inc. · Feb 1984