Cleared Traditional

K093186 - AMBU ASCOPE AND MONITOR

K093186 is an FDA 510(k) clearance for AMBU ASCOPE AND MONITOR, manufactured by Ambu A/S. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K093186 · Ambu A/S · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
189d
Days
Class 2
Risk

K093186 is an FDA 510(k) clearance for the AMBU ASCOPE AND MONITOR. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Ambu A/S (Glen Burnie, US). The FDA issued a Cleared decision on April 16, 2010 after a review of 189 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ambu A/S devices

FDA 510(k) Submission Details - K093186

510(k) Number K093186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2009
Decision Date April 16, 2010
Days to Decision 189 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
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 slower than avg
Panel avg: 140d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 136
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K093186.
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE
K131254 · Kimberly-Clark Corp. · Aug 2013
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
K120985 · Kimberly-Clark Corp. · Dec 2012
AMBU ASCOPE 2
K110962 · Ambu A/S · Nov 2011
TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT
K091761 · Teleflexmedical, Inc. · Oct 2009
PORTEX TRACHEAL TUBE, SIZES 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5
K083119 · Smiths Medical Asd, Inc. · Jun 2009
TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES
K090352 · Covidien · Apr 2009