Cleared Traditional

K042184 - GOODKNIGHT H20, MODEL M-114600-00

K042184 is an FDA 510(k) clearance for GOODKNIGHT H20, manufactured by Mallinckrodt Developpement France. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K042184 · Mallinckrodt Developpement France · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
151d
Days
Class 2
Risk

K042184 is an FDA 510(k) clearance for the GOODKNIGHT H20, MODEL M-114600-00. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Mallinckrodt Developpement France (Villers-Les-Nancy Cedex, FR). The FDA issued a Cleared decision on January 10, 2005 after a review of 151 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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.

FDA 510(k) Submission Details - K042184

510(k) Number K042184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2004
Decision Date January 10, 2005
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 Consultant

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Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 179
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