Cleared Traditional

K821584 - EPISTAXIS CATHETER/KIT

K821584 is an FDA 510(k) clearance for EPISTAXIS CATHETER/KIT, manufactured by Bivona Medical Technologies. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K821584 · Bivona Medical Technologies · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1982
Decision
13d
Days
Class 1
Risk

K821584 is an FDA 510(k) clearance for the EPISTAXIS CATHETER/KIT. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Bivona Medical Technologies (Mchenry, US). The FDA issued a Cleared decision on June 14, 1982 after a review of 13 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bivona Medical Technologies devices

FDA 510(k) Submission Details - K821584

510(k) Number K821584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1982
Decision Date June 14, 1982
Days to Decision 13 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 90d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

EMX Device Classification - Class 1, General Controls

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 18
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K821584.
EPISTAXIS NASAL BALLOON CATHETER
K921199 · Smith & Nephew Richards, Inc. · Jul 1992
MODIFIED BIVONA EPISTAXIS CATHETER
K900583 · Bivona Medical Technologies · Aug 1990
FOX POST NASAL BALLOON CATHETER
K841040 · Inmed Corp. · Aug 1984
GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.
K811496 · Narco Scientific · Jun 1981
NASOSTAT
K800175 · Edward Weck, Inc. · Feb 1980