510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K921199Substantially Equivalent

Epistaxis Nasal Balloon Catheter

Smith & Nephew Richards, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921199 is the FDA 510(k) clearance record for EPISTAXIS NASAL BALLOON CATHETER, a class I device, cleared for Smith & Nephew Richards, Inc. on under FDA product code EMX (Balloon, Epistaxis). FDA records list 87 510(k) clearances for Smith & Nephew Richards, Inc., from to . As of , FDA records show no recalls naming K921199.

Clearance record

Decision date
Received
(118 days to decision)
Product code
EMX Balloon, Epistaxis
Regulation
21 CFR 874.4100
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Smith & Nephew Richards, Inc. 1450 Brooks Rd., Memphis TN
510(k) summary
Summary
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EMX, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260