510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962400Substantially Equivalent

Air Max External Nasal Dilator Strip

American White Cross, Inc., Dayville CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962400 is the FDA 510(k) clearance record for AIR MAX EXTERNAL NASAL DILATOR STRIP, a class I device, cleared for American White Cross, Inc. on under FDA product code LWF (Dilator, Nasal). FDA records list 10 510(k) clearances for American White Cross, Inc., from to . As of , FDA records show no recalls naming K962400.

Clearance record

Decision date
Received
(80 days to decision)
Product code
LWF Dilator, Nasal
Regulation
21 CFR 874.3900
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
American White Cross, Inc. 349 Lake Rd., Dayville CT
510(k) summary
Statement
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