Cleared Traditional

K843846 - UNIVERSAL-BODYTEST (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K843846 · Erich Jaeger, Inc. · Anesthesiology device
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Feb 1985
Decision
136d
Days
Class 2
Risk

K843846 is an FDA 510(k) clearance for the UNIVERSAL-BODYTEST. Classified as Plethysmograph, Pressure (product code CCM), Class II - Special Controls.

Submitted by Erich Jaeger, Inc. (Walker, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 136 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. 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

Submission Details

510(k) Number K843846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1984
Decision Date February 14, 1985
Days to Decision 136 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 139d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.