Cleared Traditional

K981966 - NOSEBLEED NOSECLIP

K981966 is an FDA 510(k) clearance for NOSEBLEED NOSECLIP, manufactured by Michael M. Knott, M.D.. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K981966 · Michael M. Knott, M.D. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
71d
Days
Class 1
Risk

K981966 is an FDA 510(k) clearance for the NOSEBLEED NOSECLIP. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Michael M. Knott, M.D. (Tahoe City, US). The FDA issued a Cleared decision on August 14, 1998 after a review of 71 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 Michael M. Knott, M.D. devices

FDA 510(k) Submission Details - K981966

510(k) Number K981966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1998
Decision Date August 14, 1998
Days to Decision 71 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
19d faster than avg
Panel avg: 90d · This submission: 71d
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 K981966.
HYDROFERA BACTERISTATIC NASAL DRESSING
K983276 · Hydrofera, LLC · Sep 1999
MEROGEL NASAL DRESSING AND SINUS STENT
K982731 · Xomed, Inc. · Feb 1999
ENTAXIS NASAL PACKING
K984069 · Les Laboratorires Brothier, S.A. · Jan 1999
ULTRACELL PACKING WITH SLEEVE
K973085 · Ultracell Medical Technologies, Inc. · Nov 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER
K973656 · Specialty Surgical Products, Inc. · Nov 1997
VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT V-2703K
K972922 · Interview Medical Technology Corp. · Oct 1997