Cleared Traditional

K121462 - EZ-BLOCKER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121462 · Ez-Blocker B.V. · Anesthesiology device
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Sep 2012
Decision
134d
Days
Class 2
Risk

K121462 is an FDA 510(k) clearance for the EZ-BLOCKER. Classified as Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (product code CBI), Class II - Special Controls.

Submitted by Ez-Blocker B.V. (Boulder, US). The FDA issued a Cleared decision on September 28, 2012 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5740 - 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 Ez-Blocker B.V. devices

Submission Details

510(k) Number K121462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2012
Decision Date September 28, 2012
Days to Decision 134 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 139d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5740
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 - CBI Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

All 33
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