Cleared Traditional

K912524 - EXPANDACEL NASAL TAMPONS

K912524 is an FDA 510(k) clearance for EXPANDACEL NASAL TAMPONS, manufactured by Surgitrend, Ltd.. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K912524 · Surgitrend, Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
73d
Days
Class 1
Risk

K912524 is an FDA 510(k) clearance for the EXPANDACEL NASAL TAMPONS, MODIFICATION. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Surgitrend, Ltd. (Englewood, US). The FDA issued a Cleared decision on August 15, 1991 after a review of 73 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 Surgitrend, Ltd. devices

FDA 510(k) Submission Details - K912524

510(k) Number K912524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date August 15, 1991
Days to Decision 73 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 89d · This submission: 73d
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 13
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K912524.
EPI-STOP EPISTAXIS CATHETER
K972077 · Boston Medical Products, Inc. · Jun 1997
HYDROCELL NASAL AND SINUS PACKS
K954491 · Smith & Nephew Richards, Inc. · Nov 1995
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
EPISTAXIS CATHETER/KIT
K821584 · Bivona Medical Technologies · Jun 1982