510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K904290Substantially Equivalent

Nozovent, Nasal Dilator

Wpm Intl AB Intl Trade & Managemet Consulting, Sweden, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904290 is the FDA 510(k) clearance record for NOZOVENT, NASAL DILATOR, a class I device, cleared for Wpm Intl AB Intl Trade & Managemet Consulting on under FDA product code LWF (Dilator, Nasal). FDA records list one 510(k) clearance for Wpm Intl AB Intl Trade & Managemet Consulting. As of , FDA records show no recalls naming K904290.

Clearance record

Decision date
Received
(337 days to decision)
Product code
LWF Dilator, Nasal
Regulation
21 CFR 874.3900
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Wpm Intl AB Intl Trade & Managemet Consulting Kungsportsavenyn 20, Sweden, SE
Third party review
No

Clearances, product code LWF

Trailing 12 months

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

FDA records show no clearances under product code LWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWF, 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