Cleared Special

K040698 - MASTERSCREEN CPX AND OXYCON CPX

K040698 is an FDA 510(k) clearance for MASTERSCREEN CPX AND OXYCON CPX, manufactured by Viasys Healthcare GmbH. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Special 510(k) pathway after a 21-day FDA review.

K040698 · Viasys Healthcare GmbH · Anesthesiology device
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Apr 2004
Decision
21d
Days
Class 2
Risk

K040698 is an FDA 510(k) clearance for the MASTERSCREEN CPX AND OXYCON CPX. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Viasys Healthcare GmbH (Yorba Linda, US). The FDA issued a Cleared decision on April 7, 2004 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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 - K040698

510(k) Number K040698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2004
Decision Date April 07, 2004
Days to Decision 21 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 140d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 53
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K040698.
LCI OPTION FOR INNOCOR
K102047 · Innovision A/S · Nov 2011
MASTERSCREEN & OXYCON CPX
K072323 · Viasys Healthcare GmbH · Oct 2007
ZAN LUNG-FUNCTION LAB
K052328 · Zan Messgerate GmbH · Dec 2005
OXYCON MOBILE
K023120 · Erich Jaeger GmbH · Nov 2003
INFANT PLETHYSMOGRAPH, MODEL 004400
K011344 · Collins Medical, Inc. · May 2002
CORTEX METAMAX
K001631 · Cortex Biophysik GmbH · Feb 2001