510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992702Substantially Equivalent

Event Allergen Barriers, Event Mattress Encasing, Event Duvet Encasing, Event Pillow Encasing, Event Bedding System

Allergy Direct, Kansas City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992702 is the FDA 510(k) clearance record for EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT PILLOW ENCASING, EVENT BEDDING SYSTEM, a class I device, cleared for Allergy Direct on under FDA product code FMW (Cover, Mattress (Medical Purposes)). FDA records list one 510(k) clearance for Allergy Direct. As of , FDA records show no recalls naming K992702.

Clearance record

Decision date
Received
(88 days to decision)
Product code
FMW Cover, Mattress (Medical Purposes)
Regulation
21 CFR 880.6190
Device class
Class I
Review panel
General Hospital
Applicant
Allergy Direct 8800 E. 63rd St., Kansas City MO
510(k) summary
Summary
Third party review
No

Clearances, product code FMW

Trailing 12 months

FDA records hold no clearances under product code FMW in the trailing twelve months.

FDA records show no clearances under product code FMW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FMW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260