Cleared Traditional

K081823 - MASTERSCREEN PAED - BABY BODY

K081823 is an FDA 510(k) clearance for MASTERSCREEN PAED - BABY BODY, manufactured by Viasys Healthcare GmbH. The device is a Class 2 Anesthesiology device with product code CCM cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K081823 · Viasys Healthcare GmbH · Anesthesiology device
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May 2009
Decision
325d
Days
Class 2
Risk

K081823 is an FDA 510(k) clearance for the MASTERSCREEN PAED - BABY BODY. Classified as Plethysmograph, Pressure (product code CCM), Class II - Special Controls.

Submitted by Viasys Healthcare GmbH (Hoechberg, DE). The FDA issued a Cleared decision on May 18, 2009 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1750 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Viasys Healthcare GmbH devices

FDA 510(k) Submission Details - K081823

510(k) Number K081823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2008
Decision Date May 18, 2009
Days to Decision 325 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 140d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCM Device Classification - Class 2, Special Controls

Product Code CCM Plethysmograph, Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1750
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 - CCM Plethysmograph, Pressure

All 7
Devices cleared under the same product code (CCM) and FDA review panel - the closest regulatory comparables to K081823.
1085 ULTIMATE E PLETHYSMOGRAPH
K943259 · Medical Graphics Corp. · Apr 1995
MASTERLAB PFT AND MASTERLAB BODY BOX
K893420 · Quinton, Inc. · Jun 1989
INFANT BODY TEST
K853390 · Erich Jaeger, Inc. · Feb 1986
SYSTEM 1085 BODY PLETHYSMOGRAPH
K852088 · Medical Graphics Corp. · Jul 1985
UNIVERSAL-BODYTEST
K843846 · Erich Jaeger, Inc. · Feb 1985
BODYSCREEN II
K843851 · Erich Jaeger, Inc. · Feb 1985