Cleared Traditional

K110962 - AMBU ASCOPE 2

K110962 is an FDA 510(k) clearance for AMBU ASCOPE 2, 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 226-day FDA review.

K110962 · Ambu A/S · Anesthesiology device
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Nov 2011
Decision
226d
Days
Class 2
Risk

K110962 is an FDA 510(k) clearance for the AMBU ASCOPE 2. 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 November 18, 2011 after a review of 226 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 - K110962

510(k) Number K110962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2011
Decision Date November 18, 2011
Days to Decision 226 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
86d slower than avg
Panel avg: 140d · This submission: 226d
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 K110962.
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