Cleared Traditional

K901310 - ULTRASTAT NASAL CATHETER

K901310 is an FDA 510(k) clearance for ULTRASTAT NASAL CATHETER, manufactured by Invotec International, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K901310 · Invotec International, Inc. · Ear, Nose, Throat device
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Jun 1990
Decision
86d
Days
Class 1
Risk

K901310 is an FDA 510(k) clearance for the ULTRASTAT NASAL CATHETER. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Invotec International, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 14, 1990 after a review of 86 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 Invotec International, Inc. devices

FDA 510(k) Submission Details - K901310

510(k) Number K901310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1990
Decision Date June 14, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 89d · This submission: 86d
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 K901310.
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
GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.
K811496 · Narco Scientific · Jun 1981