Cleared Special

K031470 - PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US

K031470 is an FDA 510(k) clearance for PURITAN BENNETT, manufactured by Tyco Healthcare Nancy. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 27-day FDA review.

K031470 · Tyco Healthcare Nancy · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
27d
Days
Class 2
Risk

K031470 is an FDA 510(k) clearance for the PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Tyco Healthcare Nancy (Pleasanton, US). The FDA issued a Cleared decision on June 5, 2003 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031470

510(k) Number K031470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2003
Decision Date June 05, 2003
Days to Decision 27 days
Submission Type Special
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
113d faster than avg
Panel avg: 140d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 462
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K031470.
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K023068 · Map Medizintechnik Fur Arzt Und Patient GmbH · May 2003
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K030798 · Resmed, Ltd. · Apr 2003
K031470 · PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US
Download PDF FDA Summary Tyco Healthcare Nancy