510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982929Substantially Equivalent

Maxair Nasal Dilator System

Hnl Technologies, San Mateo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982929 is the FDA 510(k) clearance record for MAXAIR NASAL DILATOR SYSTEM, a class I device, cleared for Hnl Technologies on under FDA product code LWF (Dilator, Nasal). FDA records list one 510(k) clearance for Hnl Technologies. As of , FDA records show no recalls naming K982929.

Clearance record

Decision date
Received
(20 days to decision)
Product code
LWF Dilator, Nasal
Regulation
21 CFR 874.3900
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Hnl Technologies 2222 Alameda De Las Pulgas, San Mateo CA
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