Cleared Special

K991150 - NELLCOR PURITAN BENNETT, GOODKNIGHT 418G

K991150 is an FDA 510(k) clearance for NELLCOR PURITAN BENNETT, manufactured by Nellcor Puritan Bennett France Dvpt.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 8-day FDA review.

K991150 · Nellcor Puritan Bennett France Dvpt. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
8d
Days
Class 2
Risk

K991150 is an FDA 510(k) clearance for the NELLCOR PURITAN BENNETT, GOODKNIGHT 418G. 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 April 14, 1999 after a review of 8 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 - K991150

510(k) Number K991150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1999
Decision Date April 14, 1999
Days to Decision 8 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
132d faster than avg
Panel avg: 140d · This submission: 8d
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 K991150.
MONARCH II MINI MASK
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REUSABLE CONTOUR II NASAL MASK
K991648 · Respironics, Inc. · May 1999
INFANT FLOW NCPAP MASKS
K984254 · Sensor Medics Corp. · Feb 1999
INVACARE CPAP
K982242 · Invacare Corp. · Jan 1999
SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K980551 · Nidek Medical Products, Inc. · Nov 1998
K991150 · NELLCOR PURITAN BENNETT, GOODKNIGHT 418G
Download PDF FDA Summary Nellcor Puritan Benne…