Cleared Traditional

K964113 - IVALON NASAL PACKING W/DRAWSTRING (8.0C...

K964113 is an FDA 510(k) clearance for IVALON NASAL PACKING W/DRAWSTRING (8.0C..., manufactured by M-Pact Worldwide Management Corp.. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K964113 · M-Pact Worldwide Management Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
23d
Days
Class 1
Risk

K964113 is an FDA 510(k) clearance for the IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIR.... Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by M-Pact Worldwide Management Corp. (Eudora, US). The FDA issued a Cleared decision on November 7, 1996 after a review of 23 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 M-Pact Worldwide Management Corp. devices

FDA 510(k) Submission Details - K964113

510(k) Number K964113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1996
Decision Date November 07, 1996
Days to Decision 23 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
66d faster than avg
Panel avg: 89d · This submission: 23d
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 K964113.
POST-STOP EPISTAXIS CATHETER
K972078 · Boston Medical Products, Inc. · Jul 1997
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
EPISTAXIS NASAL BALLOON CATHETER
K921199 · Smith & Nephew Richards, Inc. · Jul 1992
MODIFIED BIVONA EPISTAXIS CATHETER
K900583 · Bivona Medical Technologies · Aug 1990