Cleared Traditional

K071575 - SANDMAN INTRO

K071575 is an FDA 510(k) clearance for SANDMAN INTRO, 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 94-day FDA review.

K071575 · Mallinckrodt Developpement France · Anesthesiology device
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Sep 2007
Decision
94d
Days
Class 2
Risk

K071575 is an FDA 510(k) clearance for the SANDMAN INTRO. 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 September 10, 2007 after a review of 94 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 - K071575

510(k) Number K071575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2007
Decision Date September 10, 2007
Days to Decision 94 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
46d faster than avg
Panel avg: 140d · This submission: 94d
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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