510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140542Substantially Equivalent

Navage Nasal Irrigator, Navage Nose Cleaner

Rhinosystems, Inc., Brooklyn Heights OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140542 is the FDA 510(k) clearance record for NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER, a class I device, cleared for Rhinosystems, Inc. on under FDA product code KMA (Irrigator, Powered Nasal). FDA records list one 510(k) clearance for Rhinosystems, Inc. As of , FDA records show no recalls naming K140542.

Clearance record

Decision date
Received
(115 days to decision)
Product code
KMA Irrigator, Powered Nasal
Regulation
21 CFR 874.5550
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Rhinosystems, Inc. 5399 Lancaster Dr. # 6, Brooklyn Heights OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KMA

Trailing 12 months

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

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