Cleared Special

K023796 - MS PAED-BABY BODY

K023796 is an FDA 510(k) clearance for MS PAED-BABY BODY, manufactured by Erich Jaeger GmbH. The device is a Class 2 Anesthesiology device with product code CCM cleared through the Special 510(k) pathway after a 110-day FDA review.

K023796 · Erich Jaeger GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
110d
Days
Class 2
Risk

K023796 is an FDA 510(k) clearance for the MS PAED-BABY BODY. Classified as Plethysmograph, Pressure (product code CCM), Class II - Special Controls.

Submitted by Erich Jaeger GmbH (Yorba Linda, US). The FDA issued a Cleared decision on March 3, 2003 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1750 - 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. Standard predicate reliance. 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 - K023796

510(k) Number K023796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2002
Decision Date March 03, 2003
Days to Decision 110 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
30d faster than avg
Panel avg: 140d · This submission: 110d
Pathway characteristics
Modification to existing cleared device.

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 9
Devices cleared under the same product code (CCM) and FDA review panel - the closest regulatory comparables to K023796.
MASTERSCREEN PAED - BABY BODY
K081823 · Viasys Healthcare GmbH · May 2009
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
COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM
K852102 · Warren E. Collins, Inc. · Jul 1985
SYSTEM 1085 BODY PLETHYSMOGRAPH
K852088 · Medical Graphics Corp. · Jul 1985
K023796 · MS PAED-BABY BODY
Download PDF FDA Summary Erich Jaeger GmbH