Cleared Traditional

K950024 - EXPANDACELL NASAL PACK WITH AIRWAY

K950024 is an FDA 510(k) clearance for EXPANDACELL NASAL PACK WITH AIRWAY, manufactured by Shippert Medical Technologies Corp.. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K950024 · Shippert Medical Technologies Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
44d
Days
Class 1
Risk

K950024 is an FDA 510(k) clearance for the EXPANDACELL NASAL PACK WITH AIRWAY. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Shippert Medical Technologies Corp. (Englewood, US). The FDA issued a Cleared decision on February 17, 1995 after a review of 44 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 Shippert Medical Technologies Corp. devices

FDA 510(k) Submission Details - K950024

510(k) Number K950024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1995
Decision Date February 17, 1995
Days to Decision 44 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
45d faster than avg
Panel avg: 89d · This submission: 44d
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 K950024.
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
FOX POST NASAL BALLOON CATHETER
K841040 · Inmed Corp. · Aug 1984