Cleared Traditional

K063501 - KNIGHTCONTROL REMOTE CONTROL

K063501 is an FDA 510(k) clearance for KNIGHTCONTROL REMOTE CONTROL, manufactured by Mallinckrodt Developpement France. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K063501 · Mallinckrodt Developpement France · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 2007
Decision
137d
Days
Class 2
Risk

K063501 is an FDA 510(k) clearance for the KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Mallinckrodt Developpement France (Pleasanton, US). The FDA issued a Cleared decision on April 6, 2007 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Mallinckrodt Developpement France devices

FDA 510(k) Submission Details - K063501

510(k) Number K063501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2006
Decision Date April 06, 2007
Days to Decision 137 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
3d faster than avg
Panel avg: 140d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 307
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