Cleared Traditional

K853390 - INFANT BODY TEST

K853390 is an FDA 510(k) clearance for INFANT BODY TEST, manufactured by Erich Jaeger, Inc.. The device is a Class 2 Anesthesiology device with product code CCM cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K853390 · Erich Jaeger, Inc. · Anesthesiology device
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Feb 1986
Decision
176d
Days
Class 2
Risk

K853390 is an FDA 510(k) clearance for the INFANT BODY TEST. Classified as Plethysmograph, Pressure (product code CCM), Class II - Special Controls.

Submitted by Erich Jaeger, Inc. (Rockford, US). The FDA issued a Cleared decision on February 5, 1986 after a review of 176 days - an extended review cycle.

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. Standard predicate reliance. 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 Erich Jaeger, Inc. devices

FDA 510(k) Submission Details - K853390

510(k) Number K853390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1985
Decision Date February 05, 1986
Days to Decision 176 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 140d · This submission: 176d
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

Devices cleared under the same product code (CCM) and FDA review panel - the closest regulatory comparables to K853390.
1085 ULTIMATE E PLETHYSMOGRAPH
K943259 · Medical Graphics Corp. · Apr 1995
MASTERLAB PFT AND MASTERLAB BODY BOX
K893420 · Quinton, Inc. · Jun 1989
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
CHEST BELLOWS, SMALL
K772367 · Honeywell, Inc. · Jan 1978