Cleared Traditional

K960228 - EXPANDACELL INJECTO-PAK NASAL PACK

K960228 is an FDA 510(k) clearance for EXPANDACELL INJECTO-PAK NASAL PACK, 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 41-day FDA review.

K960228 · Shippert Medical Technologies Corp. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
41d
Days
Class 1
Risk

K960228 is an FDA 510(k) clearance for the EXPANDACELL INJECTO-PAK NASAL PACK. 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 27, 1996 after a review of 41 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 - K960228

510(k) Number K960228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1996
Decision Date February 27, 1996
Days to Decision 41 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
49d faster than avg
Panel avg: 90d · This submission: 41d
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 30
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K960228.
IVALON NASAL PACKING W/DRAWSTRING (8.0CM & 4.5CM), IVALON NASAL PACKING W/AIRWAY TUBE & DRAWSTRING, IVALON CONTOUR NASAL
K964113 · M-Pact Worldwide Management Corp. · Nov 1996
RAND NASAL PACKING
K963856 · Rand Scientific Corp. · Oct 1996
EXPANDACELL INJECTO-PAK
K962133 · Shippert Medical Technologies Corp. · Aug 1996
HYDROCELL NASAL AND SINUS PACKS
K954491 · Smith & Nephew Richards, Inc. · Nov 1995
EPISTAXIS BALLOON CATHETER WITH PACKING
K945554 · Ultracell Medical Technologies, Inc. · Feb 1995
ANTERIOR/POSTERIOR EPISTAXIS CATHETER
K945556 · Ultracell Medical Technologies, Inc. · Jan 1995