Cleared Traditional

K921199 - EPISTAXIS NASAL BALLOON CATHETER

K921199 is the FDA 510(k) clearance for EPISTAXIS NASAL BALLOON CATHETER by Smith & Nephew Richards, Inc.. It is a Class 1 Ear, Nose, Throat device (product code EMX) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K921199 · Smith & Nephew Richards, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
118d
Days
Class 1
Risk

K921199 is an FDA 510(k) clearance for the EPISTAXIS NASAL BALLOON CATHETER. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on July 8, 1992 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4100 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K921199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1992
Decision Date July 08, 1992
Days to Decision 118 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 89d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EMX Balloon, Epistaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EMX Balloon, Epistaxis

All 12
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K921199.
EPI-MAX EPISTAXIS CATHETER
K972076 · Boston Medical Products, Inc. · Jun 1997
EPI-STOP EPISTAXIS CATHETER
K972077 · Boston Medical Products, Inc. · Jun 1997
HYDROCELL NASAL AND SINUS PACKS
K954491 · Smith & Nephew Richards, Inc. · Nov 1995
MODIFIED BIVONA EPISTAXIS CATHETER
K900583 · Bivona Medical Technologies · Aug 1990
FOX POST NASAL BALLOON CATHETER
K841040 · Inmed Corp. · Aug 1984
EPISTAXIS CATHETER/KIT
K821584 · Bivona Medical Technologies · Jun 1982