Cleared Abbreviated

K020886 - PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US (FDA 510(k) Clearance)

Also includes:
PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K020886 · Tyco Healthcare Nancy · Anesthesiology device
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Nov 2002
Decision
228d
Days
Class 2
Risk

K020886 is an FDA 510(k) clearance for the PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Tyco Healthcare Nancy (Villers-Les-Nancy Cedex, FR). The FDA issued a Cleared decision on November 1, 2002 after a review of 228 days - an extended review cycle.

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 Tyco Healthcare Nancy devices

Submission Details

510(k) Number K020886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2002
Decision Date November 01, 2002
Days to Decision 228 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 139d · This submission: 228d
Pathway characteristics
Standards-based clearance path.

Device Classification

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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