Cleared Abbreviated

K993584 - MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2

K993584 is an FDA 510(k) clearance for MALLINCKRODT, manufactured by Nellcor Puritan Bennett France Dvpt.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Abbreviated 510(k) pathway after a 137-day FDA review.

K993584 · Nellcor Puritan Bennett France Dvpt. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
137d
Days
Class 2
Risk

K993584 is an FDA 510(k) clearance for the MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett France Dvpt. (Villers-Les-Nancy Cedex, FR). The FDA issued a Cleared decision on March 7, 2000 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nellcor Puritan Bennett France Dvpt. devices

FDA 510(k) Submission Details - K993584

510(k) Number K993584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 1999
Decision Date March 07, 2000
Days to Decision 137 days
Submission Type Abbreviated
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
3d faster than avg
Panel avg: 140d · This submission: 137d
Pathway characteristics
Standards-based clearance path.

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)

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