510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K896248Substantially Equivalent

Innovations Nasal Tampon

Innovations by Necessity, Inc., Corona Del Mar CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896248 is the FDA 510(k) clearance record for INNOVATIONS NASAL TAMPON, a class I device, cleared for Innovations by Necessity, Inc. on under FDA product code EMX (Balloon, Epistaxis). FDA records list one 510(k) clearance for Innovations by Necessity, Inc. As of , FDA records show no recalls naming K896248.

Clearance record

Decision date
Received
(165 days to decision)
Product code
EMX Balloon, Epistaxis
Regulation
21 CFR 874.4100
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Innovations by Necessity, Inc. 3334 E. Coast Hwy.,, Corona Del Mar CA
Third party review
No

Clearances, product code EMX

Trailing 12 months

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

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